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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
143
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).
Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85
The WOMAC is a self-administered and health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a visual analog scale (VAS) of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.
Time frame: Day 29 and Day 85
Change From Day 29 in Pain Intensity Score at Day 85
Pain intensity was evaluated by 11- point numeric rating scale ranging from 0 to 10 where, 0=no pain and 10=pain as bad as you can imagine.
Time frame: Day 29 and Day 85
Number of Participants With Pain Relief
Pain relief was assessed by using a 6-point scale ranging from -1 to 4 where, -1=pain aggravated, 0=no change, 1=slightly relieved, 2=moderately relieved, 3=considerably relieved, and 4=pain completely disappeared. Participants with pain slightly relieved, moderately relieved and completely disappeared were considered as pain relieved.
Time frame: Day 29, Day 57 and Day 85
Number of Participants With Overall Assessment on Study Drug by Participants
Participants' overall assessment on study drug was done by using a 5-point scale ranging from -2 to 2 where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good. Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.
Time frame: Day 85
Number of Participants With Overall Assessment on Study Drug by Investigator
Investigator was completed overall assessment on study drug by using a 5-point scale (-2 to 2; where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good). Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.
Time frame: Day 85
Number of Participants With Categorical Swelling
Swelling was assessed by using a 4-point scale ranging from 0 to 3 where, 0=no swelling, 1=presence of cross fluctuation of fluid (PCFF), 2=patellar ballotment, and 3=swelling that distort the joint contours (SDJC).
Time frame: Day 29, Day 57 and Day 85
Number of Participants With Categorical Tenderness
Tenderness was assessed by using a 4-point scale 0 to 3 where, 0= no tenderness, 1= complaint of tenderness, 2=complaint of tenderness with wincing (CTW), and 3=wincing and attempt to withdraw.
Time frame: Day 29, Day 57 and Day 85
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