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
Intervention: Meloxicam; Aceclofenac; Tramadol Hydrochloride Plus Acetaminophen
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: WOMAC; Knee osteoarthritis pain; Pain intensity; Tramadol; Acetaminophen; Meloxicam; Aceclofenac

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have suffered from knee osteoarthritis at least for one year and meet
             the criteria of American College of Rheumatology

          -  Participants who are taking stable dose of meloxicam 7.5 milligram (mg) or 15 mg daily
             or aceclofenac 100 mg twice a day at least for four weeks

          -  Participants whose mean pain intensity has been 5 or higher on the numeric rating
             scale (NRS) for the last 48 hours

          -  Participants whose general health conditions are favorable, according to the criteria
             below: Medical and medication history, Physical examination before the study
             medication administration, Vital signs: Blood pressure, pulse, Clinical laboratory
             tests: Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate
             transaminase (SGPT) less-than or equal to (=<) 2 X normal range, Renal function:
             Creatinine less than (<) 2.0 milligrams per deciliter (mg/dl)

          -  Female participants of childbearing potential to use the proper contraceptive methods
             during the study period (Urine pregnancy test prior to the study participation should
             be negative)

        Exclusion Criteria:

          -  Participants who are applicable to Kellgren and Lawrence grade

          -  Participants who had failed tramadol treatment before or stopped taking tramadol due
             to adverse event(s)

          -  Participants who are applicable to one of the following conditions: Rheumatoid
             arthritis, Ankylosing spondylitis, Active gout or active pseudo-gout, Diagnosis of
             fibromyalgia (according to ACR Criteria), Anserine bursitis, Major trauma of the
             target joint within six months prior to the study medication administration, Infection
             of the target joint within six months prior to the study medication administration,
             Apparent avascular necrosis of the target joint within six months prior to the study
             medication administration, Anatomical deformities of the target joint, which may
             interfere with assessment of the target joint, Surgical procedures associated with the
             target joint within one year prior to the study medication administration,
             Arthroscopic procedures associated with the target joint within six months prior to
             the study medication administration

          -  Participants who have one of the following diseases: Significantly unstable diseases
             such as sleep disorder (e.g., sleep apnea or narcolepsy) or dementia, Functional
             damage or disease which may cause malabsorption, excessive accumulation, or metabolism
             or excretion disorder

          -  Participants who are pregnant or breast-feeding