RCT, Blinded, 2-Arm Efficacy Study of IP and Placebo in Patients With Chronic Pain Related to Osteoarthritis of the Knee
Status:
Recruiting
Trial end date:
2022-10-19
Target enrollment:
Participant gender:
Summary
It is a Phase III efficacy study as the title 'A randomized, double-blind, parallel-arm study
comparing the efficacy of investigational product "Ibuprofen Modified-Release Tablets 800 mg"
and placebo in patients with chronic pain related to osteoarthritis of the knee.' The primary
objective is to determine the analgesic efficacy of orally administered IBUMR in patients
with osteoarthritis (OA) of the knee.
The Secondary objectives are to compare the treatment effect on patient pain, function and
stiffness between IBUMR- and placebo-treated patients as measured by the Western Ontario and
McMaster Osteoarthritis Index (WOMAC), to compare the treatment effect on Patient Global
Assessment on Disease Activity between IBUMR- and placebo-treated patients, to compare the
treatment effect on Investigator's Global Assessment on Disease Activity between IBUMR- and
placebo-treated patients, to compare the use of analgesic rescue medicine between IBUMR- and
placebo-treated patients, to determine the safety profile of IBUMR.