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Also known as KETOPROFEN(RP19583)
KETOPROFEN · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| FDC KETOPROFEN+OMEPRAZOLE | EXPERIMENTAL | One capsule of Ketoprofen 200 mg + Omeprazole 20 mg FDC once daily Treatment duration: 4 weeks |
| Ketoprofen lysinate 12.5 mg | EXPERIMENTAL | - |
| Ketoprofen lysinate 6.25 mg | EXPERIMENTAL | - |
| Matching placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | Ketoprofen 100 mg b.i.d. for 5 days |
| 2 | EXPERIMENTAL | Ketoprofen 150 mg b.i.d. for 5 days |
| Name | Type | Description |
|---|---|---|
| FDC KETOPROFEN+OMEPRAZOLE | DRUG | Ketoprofen + Omeprazole FDC once daily for 4 weeks |
| KETOPROFEN(RP19583) | DRUG | Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days |
| Placebo | DRUG | Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days |
| ketoprofen 100 mg | DRUG | 100 mg b.i.d. for 5 days |
| ketoprofen | DRUG | 150 mg b.i.d. for 5 days |
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...
KETOPROFEN is used for the treatment of pain. It is a small molecule developed by Sanofi (ticker SNY) and has been studied in Phase 3 clinical trials for pain indications, including post-traumatic or rheumatologic acute affections of the locomotor apparatus and sore throat. It is also being evaluated in a fixed-dose combination with omeprazole.
KETOPROFEN targets PTGS2 and PTGS1, also known as cyclooxygenase-2 (COX-2) and cyclooxygenase-1 (COX-1). It acts as an inhibitor of these enzymes. By inhibiting PTGS1 and PTGS2, KETOPROFEN reduces the production of prostaglandins, which are mediators of pain and inflammation.
KETOPROFEN is developed by Sanofi, which trades under the ticker SNY. Sanofi has conducted Phase 3 clinical trials of KETOPROFEN for pain indications, including studies of a fixed-dose combination with omeprazole and a lysine salt lozenge formulation.
KETOPROFEN is in Phase 3 clinical development. Three Phase 3 trials have been completed, with a total enrollment of 1,262 participants. These trials were randomized, double-blind, and placebo-controlled. No active trials are currently ongoing.
KETOPROFEN has been studied in three completed Phase 3 trials: NCT00971581, which evaluated a fixed-dose combination of ketoprofen plus omeprazole; NCT00929877 (KRYSTAL), which tested ketoprofen lysinate sore throat lozenges; and NCT00810121 (BIPROPAIN), which compared Bi-Profenid 200 mg versus 300 mg in acute locomotor pain.