Preliminary study of the safety and efficacy of SC-58635, a novel cyclooxygenase 2 inhibitor: efficacy and safety in two placebo-controlled trials in osteoarthritis and rheumatoid arthritis, and studies of gastrointestinal and platelet effects

Arthritis Rheum. 1998 Sep;41(9):1591-602. doi: 10.1002/1529-0131(199809)41:9<1591::AID-ART9>3.0.CO;2-J.


Objective: To investigate the efficacy and safety of SC-58635 (celecoxib), an antiinflammatory and analgesic agent that acts by selective cyclooxygenase 2 (COX-2) inhibition and is not expected to cause the typical gastrointestinal (GI), renal, and platelet-related side effects associated with inhibition of the COX-1 enzyme.

Methods: Four phase II trials were performed: a 2-week osteoarthritis efficacy trial, a 4-week rheumatoid arthritis efficacy trial, a 1-week endoscopic study of GI mucosal effects, and a 1-week study of effects on platelet function.

Results: The 2 arthritis trials identified SC-58635 dosage levels that were consistently effective in treating the signs and symptoms of arthritis and were distinguished from placebo on standard arthritis scales. In the upper GI endoscopy study, 19% of subjects receiving naproxen (6 of 32) developed gastric ulcers, whereas no ulcers occurred in subjects receiving SC-58635 or placebo. The study of platelet effects revealed no meaningful effect of SC-58635 on platelet aggregation or thromboxane B2 levels, whereas aspirin caused significant decreases in 2 of 3 platelet aggregation measures and thromboxane B2 levels. In all 4 trials, SC-58635 was well tolerated, with a safety profile similar to that of placebo.

Conclusion: SC-58635 achieves analgesic and antiinflammatory efficacy in arthritis through selective COX-2 inhibition, without showing any evidence of 2 of the toxic effects of COX-1 inhibition associated with nonsteroidal antiinflammatory drugs.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Arthritis, Rheumatoid / drug therapy*
  • Aspirin / therapeutic use
  • Celecoxib
  • Cyclooxygenase Inhibitors / adverse effects
  • Cyclooxygenase Inhibitors / therapeutic use*
  • Endoscopy
  • Female
  • Humans
  • Knee Joint / drug effects
  • Knee Joint / pathology
  • Male
  • Middle Aged
  • Naproxen / adverse effects
  • Osteoarthritis / drug therapy*
  • Platelet Aggregation / drug effects
  • Platelet Aggregation Inhibitors / therapeutic use
  • Pyrazoles
  • Safety
  • Severity of Illness Index
  • Stomach Ulcer / chemically induced
  • Stomach Ulcer / pathology
  • Sulfonamides / adverse effects
  • Sulfonamides / therapeutic use*
  • Thromboxane B2 / blood
  • Treatment Outcome


  • Cyclooxygenase Inhibitors
  • Platelet Aggregation Inhibitors
  • Pyrazoles
  • Sulfonamides
  • Thromboxane B2
  • Naproxen
  • Celecoxib
  • Aspirin