A Comparative Study on Tramadol 37.5mg/Acetaminophen 325mg Tablets Maintenance Versus Non-steroidal Anti-inflammatory Drugs(NSAIDs) Maintenance in Patients With Knee Osteoarthritis
The purpose of this study is to compare the effectiveness of tramadol 37.5mg/acetaminophen 325mg maintenance with that of NSAID maintenance in patients whose pain was relieved after the add-on treatment of tramadol hydrochloride to NSAID.
Drug: tramadol hydrochloride, acetaminophen, meloxicam, aceclofenac
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- WOMAC total score: Day 85 - Day 29 (randomization)
- Pain intensity, pain relief, subject's and investigator's overall evaluation on the study medication, swelling and tenderness
|Study Start Date:||May 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Osteoarthritis(OA) is a typical musculoskeletal condition that causes pain. It affects women more than men, and its prevalence increases with age. The worldwide prevalence of symptomatic OA among those aged>60 years is estimated to be 9.6% in men and 18.0% in women. OA affects an estimated 139 million worldwide. The severity of OA symptoms is influenced by attitudes, anxiety, depression, and activities of daily living. In the absence of a cure other than joint replacement surgery, patients with severe OA require pharmacologic control of their pain. NSAIDs, acetaminophen, tramadol, tramadol combination, glucosamine and chondroitin sulfate have been used to treat osteoarthritis pain. Tramadol/acetaminophen add-on treatment to non-steroidal anti-inflammatory drugs(NSAIDs) for the osteoarthritis flare pain improved significantly in pain intensity and pain relief, compared with placebo. Also, tramadol/acetaminophen add-on treatment for three months in the osteoarthritis patients taking NSAIDs had significantly relieved pain. In routine clinical practice, if pain is relieved to some degree after tramadol/acetaminophen and NSAID combination therapy, one of them is discontinued. This clinical study will compare the effectiveness of tramadol 37.5mg/acetaminophen 325mg maintenance with that of NSAIDs maintenance after their combination therapy. The study hypothesis is that the treatment effect of tramadol 37.5mg/acetaminophen 325mg group is not inferior compared to that of NSAIDs group for treatment of knee osteoarthritis pain. This is a multicenter, randomized, open comparative study to compare the efficacy of tramadol 37.5mg/acetaminophen 325mg maintenance with that of NSAIDs maintenance in patients whose pain was relieved after the add-on treatment of tramadol 37.5mg/acetaminophen 325mg to NSAID. All patients will receive tramadol 37.5mg/acetaminophen 325mg 1 tablet at night for the first 3 days, then 1 tablet twice a day for 4 days, and 1 tablet three times a day for next 3 days with NSAIDs(meloxicam or aceclofenac). If there is no pain relief, tramadol 37.5mg/acetaminophen 325mg can be increased up to 8 tablets per day for day 11~28 with NSAIDs, and then the patients will be randomized into 2 treatment groups at Visit 3(day 29). Tramadol 37.5mg/acetaminophen 325mg group will receive the dosage that is fixed at Visit 3 and this dosage shoud be maintained for day 29~85. There are two groups in NSAIDs group. Meloxicam group will receive 7.5mg or 15mg per day for day 29~85. Aceclofenac group will receive 100mg twice a day for day 29~85. All patients receive tramadol 37.5mg/acetaminophen 325mg (T/A) 1T hs for 3 days followed by 1T twice a day for 4 days, then, 1T three times a day for 3 days with NSAIDs. T/A can be increased up to 8Ts/day for day 11~28 with NSAIDs. After randomization at Visit 3, T/A group will take the dosage fixed at Visit 3 and it shoud be maintained for day 29~85. There are two NSAID groups. Meloxicam group take 7.5mg or 15mg daily for day 29~85. Aceclofenac group take 100mg twice a day for day 29~85.