Study of Celecoxib and Acetaminophen Combination Versus Celecoxib Alone for Pain Relief in Adults with Knee or Hip Osteoarthritis Experiencing Flare-Ups

What this Trial Is About

Researchers are conducting a Phase III, randomized, double-blind clinical trial to compare the effectiveness and safety of a fixed-dose combination of celecoxib and acetaminophen against celecoxib alone for treating pain caused by acute flare-ups of osteoarthritis. The study focuses on patients with osteoarthritis experiencing increased joint pain, aiming to assess pain relief and safety over six weeks. Participants will be randomly assigned to one of three groups receiving either celecoxib plus acetaminophen tablets or celecoxib capsules, all taken orally once daily for six weeks. During the study, participants can take naproxen as a rescue medication if authorized by the principal investigator. The trial includes scheduled visits at the start and during weeks 1, 2, 4, and 6 to monitor progress. Throughout the six-week follow-up, participants will attend five clinic visits for assessments including pain measurement using standardized criteria like OMERACT-OARSI, WOMAC questionnaire, and Visual Analog Scale. Quality of life will also be evaluated. Adverse events will be recorded via patient diaries. The study aims to compare pain response rates and safety between treatments, with careful monitoring of side effects and overall patient wellbeing.

Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation