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PF-00345439

Phase 3

Pain | Small molecule | Pain |Filana Therapeutics, Inc.|Last Updated: Apr 4, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment823

FDA Designations

No designations recorded

Clinical trial landscape

PF-00345439 · 2 trials · 2 indications

Phase 3 1Phase 1 1
NCT01559701Long-term Safety of PF-00345439 (Oxycodone)Pain
COMPLETED823 Analytics
PHASE3COMPLETED
Long-term Safety of PF-00345439 (Oxycodone)
PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Number and Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
12 months
Drug Liking: Peak Effect (Emax)
12 hours

Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely.

High: Peak Effect (Emax)
12 hours

High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely.

Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours
2 hours

Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely.

High: Area Under Effect Curve (AUE) From 0-2 Hours
2 hours

High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely.

Secondary Endpoints

Percent change from baseline Pain Intensity Scale
baseline 1, 3, 6, 9 and 12 months
Quality of Analgesia - patient reported outcome of analgesia quality using ratings of excellent, very good, good, fair, or poor.
1, 3, 6, 9 and 12 months
Global Assessment of Study Medication - patient reported outcome using ratings of excellent, very good, good, fair, or poor.
1, 3, 6, 9 and 12 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-00345439 (oxycodone)EXPERIMENTALPF-00345439 (oxycodone)
Treatment APLACEBO_COMPARATORPlacebo solution +placebo capsule + placebo capsule chewed.
Treatment BEXPERIMENTALPF-00345439 taken whole + placebo solution + placebo chewed
Treatment CEXPERIMENTALPF-00345439 chewed + placebo solution + placebo taken whole
Treatment DACTIVE_COMPARATOROxycodone HCl immediate-release 40 mg tablets (eg, 2 x 5 mg + 1 x 30 mg) + placebo taken whole + placebo chewed

Interventions

NameTypeDescription
PF-00345439DRUG5-80 mg twice-a-day for 12 months
CapsuleDRUGTaken once
oxycodoneDRUG40 mg solution, taken once
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Males and females who are ≥ 18 and ≤ 75 years of age with moderate to severe pain in one or more hip or knee joint(s) caused by osteoarthritis for at least three months prior to the Baseline Visit or persistent moderate to severe low back pain for at least six months while reg...

Countries:United States
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Frequently asked questions about PF-00345439

What is PF-00345439 used for?

PF-00345439 is a small molecule being developed for pain management. It has been studied in clinical trials for pain and in opioid users. The drug is currently in Phase 1 development and is being developed by Cassava Sciences, Inc.

Who makes PF-00345439?

PF-00345439 is being developed by Cassava Sciences, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy for pain-related conditions.

What phase is PF-00345439 in?

PF-00345439 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed to assess its safety and potential effects.

What clinical trials has PF-00345439 been in?

PF-00345439 has been studied in two completed clinical trials. One trial (NCT01559701) evaluated long-term safety in 823 participants with pain. Another trial (NCT01986283) assessed abuse potential in 67 opioid users. Both trials were randomized, double-blind, and placebo-controlled.

Is PF-00345439 the same as oxycodone?

PF-00345439 is not the same as oxycodone. A clinical trial titled "Long-term Safety of PF-00345439 (Oxycodone)" suggests the drug may be related to or compared with oxycodone, but PF-00345439 is a distinct investigational compound being developed by Cassava Sciences.