At a glance
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A Comparison of Tramadol/Acetaminophen Tablets Maintenance Versus NSAID Maintenance After Tramadol/Acetaminophen and NSAID Combination Therapy in Knee Osteoarthritis Patients: Multicenter, Randomized, Open Comparative Study
In Brief
A Phase 4 clinical trial evaluating Meloxicam, Aceclofenac, and 1 other intervention for Osteoarthritis. Completed, enrolled 143 participants.
Detailed Summary
The purpose of this study is to compare the effectiveness of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg maintenance with that of non-steroidal anti-inflammatory drugs (NSAIDs) maintenance in participants with knee osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) whose pain was relieved after the add-on treatment of tramadol hydrochloride to NSAIDs.
Study Details
Timeline
Interventions
Meloxicam 7.5 mg or 15 mg per day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and meloxicam 7.5 mg or 15 mg per day from Day 29 to Day 85.
Aceclofenac 100 mg twice a day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and aceclofenac 100 mg twice a day from Day 29 to Day 85.
Fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with NSAIDs (meloxicam \[7.5 mg or 15 mg once daily\] or aceclofenac \[100 mg twice daily\]) from Day 1 to Day 28, and fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose will be 8 tablets).