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IBU

Phase 3

Pain | Small molecule | Pain |Pfizer, Inc.|Last Updated: Sep 30, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment328
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02837952A Study of Ibuprofen (IBU) 250mg/APAP 500mg In The Treatment Of Post-Surgical Dental PainPHASE3 COMPLETED 123Aug 31, 2016Feb 1, 2017Mar 5, 20181 United States
NCT01794923Topical Ibuprofen for Delayed Onset Mulscle SorenessPHASE3 COMPLETED 205Jun 13, 2013Mar 29, 2014Sep 30, 20211 United States
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Study Endpoints
Primary Endpoints
Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 24 Hours Post-dose (SPID11 [0-24])
0 to 24 hours post dose

Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 \[0-24\]: Time-weighted sum of Pain Intensity Difference (PID) scores over 24 hours. SPID11 score range was -120 (worst score) to 240 (best score) for SPID 0-24. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).

Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 0-24 Hours Post-Dose 1 (MSM 0-24 )
Baseline, 0 to 24 hours post-Dose 1 on Day 1

Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate muscle soreness on movement (MSM). Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11 point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity. Change from baseline in the time-weighted sum of MSM over 0-24 hours was derived as the MSM change from baseline multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 0 to Hour 24 (range: -96 to 240, higher score indicates better response).

Secondary Endpoints
Time-weighted Sum of Pain Intensity Difference Score on 11-Point Numerical Scale (SPID11) From 0 to 8, 6 to 8, 0 to 16, 8 to 16 and 0 to 48 Hours Post-dose
0 to 8 hours, 6 to 8 hours, 0 to 16 hours, 8 to 16 hours and 0 to 48 hours post dose
Duration of Relief After First Dose
Up to 8 hours after first dose
Time to Onset of "Meaningful" Pain Relief After First Dose
Up to 8 hours after first dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Fixed Dose Combination(FDC) IBU/APAP 250 mg/500 mgACTIVE_COMPARATORFDC IBU/APAP 250 mg/500 mg
PlaceboPLACEBO_COMPARATORPlacebo
Ibuprofen 5% topical gel BIDEXPERIMENTALIBU BID (Treatment A)
Placebo topical gel BIDPLACEBO_COMPARATORPlacebo BID (Treatment B)
Ibuprofen 5% topical gel TIDEXPERIMENTALIBU TID (Treatment C)
Placebo topical gel TIDPLACEBO_COMPARATORPlacebo TID (Treatment D)
Interventions
NameTypeDescription
FDC IBU/APAP 250 mg/500 mgDRUGFDC IBU/APAP 250 mg/500 mg
PlaceboDRUGPlacebo
IBU BIDDRUG10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days
Placebo BIDDRUG10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days
IBU TIDDRUG10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days
Placebo TIDDRUG10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 days
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria 1. Males and females 18 years to 40 years of age (inclusive). 2. Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction. 3. Subject must have at least moderate pain on the 4 point c...

Countries:United States
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