A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis
A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis
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.
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.
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