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PF-04383119

Phase 2

Cystitis, Interstitial | Small molecule | Urology |Pfizer, Inc.|Last Updated: Jul 12, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

PF-04383119 · 3 trials · 3 indications

Phase 2 3
NCT00669409A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The KneeOsteoarthritis, Knee
COMPLETED83 Analytics
NCT00601484An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial CystitisCystitis, Interstitial
COMPLETED65 Analytics
NCT00584870RN624 In Adult Patients With Chronic Low Back PainLow Back Pain
COMPLETED220 Analytics
PHASE2COMPLETED
A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee
Osteoarthritis, Knee
NCT0066940983
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PHASE2COMPLETED
An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
Cystitis, Interstitial
NCT0060148465
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PHASE2COMPLETED
RN624 In Adult Patients With Chronic Low Back Pain
Low Back Pain
NCT00584870220
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Study Endpoints

Primary Endpoints

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Day 1 up to Day 92 for tanezumab 10, 25, 50 mcg/kg group and matching placebo group (Part 1, 2); Day 1 up to Day 120 for tanezumab 100 mcg/kg group and matching placebo group (Part 1, 2), 200 mcg/kg group and matching placebo group (Part 1)

An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent: events between first dose of study drug and up to Day 1 through Day 120 (Part 1 and 2) were absent before treatment or that worsened relative to pretreatment state

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline
Baseline (Part 1 and Part 2)

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1
Day 1 (Part 1 and 2)

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5
Day 4/5 (Part 1 and 2)

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1
Week 1 (Part 1 and Part 2)

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2
Week 2 (Part 1 and Part 2)

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3
Week 3 (Part 1 and 2)

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4
Week 4 (Part 1 and Part 2)

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13
Week 13 (Part 1 and Part 2)

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17
Week 17 (Part 1 and Part 2)

The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory.

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1
Baseline, Week 1 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2
Baseline, Week 2 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3
Baseline, Week 3 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4
Baseline, Week 4 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5
Baseline, Week 5 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6
Baseline, Week 6 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7
Baseline, Week 7 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 10 0= extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8
Baseline, Week 8 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9
Baseline, Week 9 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10
Baseline, Week 10 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11
Baseline, Week 11 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12
Baseline, Week 12 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13
Baseline, Week 13 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary.

Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1
Baseline, Week 1 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2
Baseline, Week 2 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3
Baseline, Week 3 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4
Baseline, Week 4 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5
Baseline, Week 5 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6
Baseline, Week 6 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7
Baseline, Week 7 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8
Baseline, Week 8 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9
Baseline, Week 9 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10
Baseline, Week 10 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11
Baseline, Week 11 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12
Baseline, Week 12 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13
Baseline, Week 13 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1
Baseline, Week 1 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 2
Baseline, Week 2 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3
Baseline, Week 3 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4
Baseline, Week 4 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5
Baseline, Week 5 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6
Baseline, Week 6 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 7
Baseline, Week 7 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 8
Baseline, Week 8 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9
Baseline, Week 9 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 10
Baseline, Week 10 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11
Baseline, Week 11 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12
Baseline, Week 12 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13
Baseline, Week 13 (Part 1 and 2)

VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1
Baseline, Week 1 (Part 1 and 2)

WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2
Baseline, Week 2 (Part 1 and 2)

WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4
Baseline, Week 4 (Part 1 and 2)

WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8
Baseline, Week 8 (Part 1 and 2)

WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0=none to 100= extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13
Baseline, Week 13 (Part 1 and 2)

WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.

Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17
Baseline, Week 17 (Part 1 and 2)

WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living.

Change From Baseline in Average Daily Pain Score at Week 6
Baseline, Week 6

Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Here, 'Number analyzed' = participants with available data for each specified category.

Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6
Baseline, Week 6

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax) - Part 1
Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1
Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1
Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
10 mcg/kgEXPERIMENTAL -
100 mcg/kgEXPERIMENTAL -
200 mcg/kgEXPERIMENTAL -
25 mcg/kgEXPERIMENTAL -
50 mcg/kgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
NaproxenACTIVE_COMPARATOR -
RN624EXPERIMENTAL -

Interventions

NameTypeDescription
PF-04383119 (tanezumab)DRUGsingle dose of 10 mcg/kg IV
PF-04383119DRUGPF-04383119 200 mcg/kg IV, single dose
PlaceboDRUGplacebo IV, single dose
NaproxenDRUGOral naproxen 500 mg twice daily for Weeks 1-12.
PF-04383119 (RN624)DRUGSingle IV infusion of 200 micrograms/kg RN624 on Day 1
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Eligibility Criteria

Age Range35 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Japanese Male or female, Age 35-65 (Part 1), Age 35-75 (Part 2) * Diagnosis of osteoarthritis (OA) of the knee based on American College of Rheumatology criteria * Knee pain, and radiographic evidence of knee OA (Kellgren-Lawrence x-ray grade ≥2) obtained within 1 year of enro...

Countries:JapanUnited States
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Frequently asked questions about PF-04383119

What is PF-04383119 used for?

PF-04383119 is an investigational small molecule being studied for the treatment of chronic low back pain, pain from interstitial cystitis, and moderate to severe pain from osteoarthritis of the knee. It has been evaluated in Phase 2 clinical trials for these pain conditions.

Who makes PF-04383119?

PF-04383119 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule in Phase 2 clinical development for pain-related indications.

What phase is PF-04383119 in?

PF-04383119 is in Phase 2 clinical development. It has completed Phase 2 trials for chronic low back pain, interstitial cystitis pain, and osteoarthritis of the knee. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PF-04383119 in?

PF-04383119 has been studied in three completed Phase 2 trials: NCT00584870 for chronic low back pain with 220 participants, NCT00601484 for interstitial cystitis pain with 65 participants, and NCT00669409 for knee osteoarthritis pain in Japanese patients with 83 participants.

Is PF-04383119 the same as RN624?

PF-04383119 is also known as RN624. One clinical trial, NCT00584870, is titled 'RN624 In Adult Patients With Chronic Low Back Pain' and evaluates the same drug compound for this condition.