A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This is a multicenter (when more than one hospital or medical school team work on a medical
      research study), randomized (the study drug is assigned by chance), open-label (all people
      know the identity of the intervention), comparative study to compare the efficacy of tramadol
      hydrochloride plus acetaminophen maintenance with that of NSAIDs maintenance in participants
      whose pain was relieved after the add-on treatment of tramadol 37.5 milligram (mg) plus
      acetaminophen 325 mg to NSAIDs. All participants will receive 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 participants
      will be randomly assigned into 2 treatment groups at Day 29 if the numerical rating scale
      score less than or equal 4. Tramadol plus acetaminophen group will receive 1 or 2 tablets
      containing tramadol 37.5 mg plus acetaminophen 325 mg 4 times daily (maximum daily dose will
      be 8 tablets) from Day 29 to Day 85 and NSAIDs group will receive either meloxicam 7.5 mg or
      15 mg per day or aceclofenac 100 mg twice a day from Day 29 to Day 85. The efficacy will be
      evaluated on Day 1, Day 29, Day 57 and Day 85. The primary efficacy end point will be
      assessed through change in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
      total score from Day 29 to Day 85. Participant's safety will be monitored throughout the
      study.
    

Intervention name(s): Meloxicam; Aceclofenac; Tramadol Hydrochloride Plus Acetaminophen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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).
Intervention MeSH terms: Acetaminophen; Meloxicam; Aceclofenac; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: WOMAC; Knee osteoarthritis pain; Pain intensity; Tramadol; Acetaminophen; Meloxicam; Aceclofenac