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KETOPROFEN

Phase 3

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment1,262

FDA Designations

No designations recorded

Clinical trial landscape

KETOPROFEN · 3 trials · 1 indication

Phase 3 3
NCT00971581Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus OmeprazolePain
COMPLETED52 Analytics
NCT00929877KRYSTAL- KetopRofen lYsinate Sore ThroAt LozengesPain
COMPLETED801 Analytics
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)Pain
COMPLETED409 Analytics
PHASE3COMPLETED
Safety, Tolerability and Efficacy Study With a Fixed-Dose Combination (FDC) Ketoprofen Plus Omeprazole
PainUnlock trial analytics
PHASE3COMPLETED
KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges
PainUnlock trial analytics
PHASE3COMPLETED
Study 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)
PainUnlock trial analytics

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 to 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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Frequently asked questions about KETOPROFEN

What is KETOPROFEN?

KETOPROFEN is a small molecule drug being developed by Sanofi (SNY) for the treatment of pain. It is currently in Phase 3 clinical development, meaning it is investigational and has not yet been approved by regulatory authorities. The drug is being studied in several clinical trials for pain-related conditions.

What is KETOPROFEN used for?

KETOPROFEN is used for the treatment of pain. Clinical trials have evaluated it in conditions such as post-traumatic or rheumatologic acute affections of the locomotor apparatus, sore throat, and pain in general. All completed trials focused on pain as the primary condition being studied.

Who makes KETOPROFEN?

KETOPROFEN is being developed by Sanofi, a pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy for pain treatment.

What phase is KETOPROFEN in?

KETOPROFEN is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. All three clinical trials for KETOPROFEN are Phase 3 studies, and they have all been completed.

What clinical trials is KETOPROFEN in?

KETOPROFEN has been studied in three completed Phase 3 clinical trials: NCT00810121, NCT00929877, and NCT00971581. These trials enrolled a total of 1,262 participants and evaluated the drug for pain, including post-traumatic or rheumatologic conditions, sore throat, and a fixed-dose combination with omeprazole.

Is KETOPROFEN the same as Bi-Profenid?

KETOPROFEN is the active ingredient in the product Bi-Profenid, which was studied in a clinical trial comparing Bi-Profenid 200mg to Bi-Profenid 300mg. The trial NCT00810121 evaluated these formulations for pain in patients with post-traumatic or rheumatologic acute affections of the locomotor apparatus.