Clinical trial NCT00635349: A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: WOMAC
Knee osteoarthritis pain
Pain intensity
Tramadol
Acetaminophen
Meloxicam
Aceclofenac
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 143
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85
timeFrame: Day 29 and Day 85
Secondary outcomes:
measure: Change From Day 29 in Pain Intensity Score at Day 85
timeFrame: Day 29 and Day 85
measure: Number of Participants With Pain Relief
timeFrame: Day 29, Day 57 and Day 85
measure: Number of Participants With Overall Assessment on Study Drug by Participants
timeFrame: Day 85
measure: Number of Participants With Overall Assessment on Study Drug by Investigator
timeFrame: Day 85
measure: Number of Participants With Categorical Swelling
timeFrame: Day 29, Day 57 and Day 85
measure: Number of Participants With Categorical Tenderness
timeFrame: Day 29, Day 57 and Day 85
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd.
name: Janssen Korea, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: