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KETOPROFEN

Phase 3

Pain | Small molecule | Pain |Sanofi|Last Updated: Jun 29, 2010

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 Trials3
Total Enrollment1,262
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00971581Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus OmeprazolePHASE3 COMPLETED 52 — — Aug 1, 2009May 1, 2010Jun 29, 20101 Mexico
NCT00929877KRYSTAL- KetopRofen lYsinate Sore ThroAt LozengesPHASE3 COMPLETED 801 — — Jun 1, 2009Apr 1, 2010May 18, 20107 Egypt, Finland +5
NCT00810121Study of Non Inferiority Bi-Profenid® 200mg Versus Bi-Profenid® 300mg Among Patients Presenting of the Post-traumatic or Rheumatologic Acute Affections of the Locomotor Apparatus (BIPROPAIN)PHASE3 COMPLETED 409 — — Nov 1, 2008Jun 1, 2009Sep 25, 20091 France
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Study Endpoints
Primary Endpoints
To confirm the efficacy of the combination
From the start to the end of the study (D 0 to D 28)
Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea
At Day 10
The TOTPAR15-120 which is the sum of each pain relief scale score
measured every 15 minutes during the 2 hours following the first study drug intake
Resting pain intensity measured using the numeric scale (NS) at the end of the day, and total intake of concomitant analgesics over 5 days. For these two parameters, the maximum value will be assigned to patients who used step II or III analgesics
between D1 and D5, at the end of the day
Secondary Endpoints
Incidence of dyspeptic symptoms: epigastric pain, dyspepsia, nausea
At Day 0, Day 4 & Day 28
Incidence of complications (perforations, ulcers, bleeding) and Incidence of fecal occult blood positivity
At study termination (Day 28)
Improvement of pain (VAS)
At study termination (Day 28)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FDC KETOPROFEN+OMEPRAZOLEEXPERIMENTALOne capsule of Ketoprofen 200 mg + Omeprazole 20 mg FDC once daily Treatment duration: 4 weeks
Ketoprofen lysinate 12.5 mgEXPERIMENTAL -
Ketoprofen lysinate 6.25 mgEXPERIMENTAL -
Matching placeboPLACEBO_COMPARATOR -
1EXPERIMENTALKetoprofen 100 mg b.i.d. for 5 days
2EXPERIMENTALKetoprofen 150 mg b.i.d. for 5 days
Interventions
NameTypeDescription
FDC KETOPROFEN+OMEPRAZOLEDRUGKetoprofen + Omeprazole FDC once daily for 4 weeks
KETOPROFEN(RP19583)DRUGOral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days
PlaceboDRUGOral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days
ketoprofen 100 mgDRUG100 mg b.i.d. for 5 days
ketoprofenDRUG150 mg b.i.d. for 5 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Adults suffering from chronic inflammatory conditions, in particular, rheumatoid polyarthritis, ankylosing spondylitis (or related syndromes, such as, Reiters syndrome, psoriatic arthritis,) with a previous history or who are at risk of developing NSAID associated benign gastr...

Countries:MexicoEgyptFinlandFranceGermanyRussiaSpain
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