RCT, Blinded, 2-Arm Efficacy Study of IP and Placebo in Patients With Chronic Pain Related to Osteoarthritis of the Knee

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2021
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.
Epistemonikos ID: 5eed92ba6ed8726f3b99fd89c4d4e379a2b0b79c
First added on: May 13, 2024