A Study on the Safety and Effectiveness of Tramadol 37.5mg/Actaminophen 325mg Versus Gabapentin in Diabetic Neuropathic Pain
The purpose of this study is to evaluate the effectiveness and safety of tramadol 37.5mg/acetaminophen 325mg compared to gabapentin in patients with diabetic neuropathic pain.
Drug: Tramadol hydrochloride; Acetaminophen; Gabapentin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of the Effectiveness and Safety Between Tramadol 37.5mg/Acetaminophen 325mg and Gabapentin for the Treatment of Painful Diabetic Neuropathy: Multicenter, Randomized, Open Comparative Study|
- Difference of pain intensity (Visit 5 - baseline)
- Pain relief, brief pain inventory, SF-36, average pain intensity(NRS), overall assessment of patient and investigator
|Study Start Date:||December 2006|
|Study Completion Date:||October 2008|
Treatment of painful diabetic neuropathy often requires multiple medications with different mechanisms of action in order to obtain an optimal analgesic effect. Painful diabetic neuropathy may be considered as a combination of nociceptive/neuropathic pain. Gabapentin has been used to treat painful diabetic neuropathy. Tramadol has been proven to be significantly effective on painful diabetic neuropathy and patients treated with tramadol have showed higher scores on physical and social function scales. The study hypothesis is that the treatment effect of tramadol 37.5mg/acetaminophen 325mg group is not inferior compared to that of gabapentin group for treatment of painful diabetic neuropathy. This is a multicenter, randomized, open comparative study to compare the effectiveness and safety between tramadol 37.5mg/acetaminophen 325mg and gabapentin for the treatment of pain in diabetic neuropathy. The patients will be randomized into 2 treatment groups. Tramadol 37.5mg/acetaminophen 325mg(T/A) group will receive 1 tablet before sleep for 3 days, then 1 tablet twice a day for 4 days followed by 1 tablet three times a day for next 7 days. If there is no pain relief, T/A 325mg can be increased up to 8tablets/day for day 15~28, and then the dosage shoud be maintained for day 29~42. Gabapentin(GB) group will receive 300mg before sleep at day 1, 300mg twice a day at day 2, and 300mg three times a day for day 3~7. Then for day 8~14, subject will receive 300mg in the morning, 300mg in the midday, 600mg in the evening. If there is no pain relief, GB can be increased up to 3600mg/day for day 15~28, and then the dosage shoud be maintained for day 29~42. Tramadol/Acetaminophen group will receive 1 tablet for 3 days, 1 tablet 2x/day for 4 days, and 1 tablet 3x/ day for next 7 days. If there is no pain relief, Tramadol/Acetaminophen can be increased up to 8T/day for day 15~28, and then shoud be maintained for day 29~42. Gabapentin group will receive 300mg hs for 3days, 300mg 2x/day for 4 days and 300mg 3x/day for next 7 days. If there is no pain relief, GB can be increased up to 3600mg/day for day 15~28, and then shoud be maintained for day 29~42.