A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of tramadol
      hydrochloride (HCl) 37.5 miligram (mg)/acetaminophen 325 mg compared to gabapentin in
      participants with diabetic neuropathic (nerve disorder caused by diabetes mellitus) pain.
    

Detailed description: 
      This is an open-label (a medical research study in which participants and researchers are
      told which treatments the participants are receiving, "unblinded"), multi-center and
      randomized (study drug is assigned by chance) study to compare the effectiveness and safety
      of tramadol HCl 37.5 mg/acetaminophen 325 mg with gabapentin in participants with diabetic
      neuropathy. The study will consist of 4 periods: Screening period (up to Day -14),
      Randomization period (Day 1), Dosage adjustment period (Day 15) and Maintenance period (Day
      43). The participants will be randomly assigned to 1 of the 2 treatment groups: tramadol HCl
      37.5 mg/acetaminophen 325 mg or gabapentin. Tramadol Hcl/acetaminophen group will receive 1
      tablet for 3 days, then 1 tablet twice daily for 4 days followed by 1 tablet thrice daily for
      next 7 days. If there is no pain relief, the dosage can be increased up to 8 tablets per day
      for Day 15 to 28, and then the increased dosage will be maintained for Day 29 to 42.
      Gabapentin group will receive 300 mg on Day 1, 300 mg twice daily on Day 2, and 300 mg thrice
      daily for Day 3 to 7. Then for Day 8 to 14, participants will receive 300 mg in the morning,
      300 mg in the midday and 600 mg in the evening. If there is no pain relief, gabapentin can be
      increased up to 3600 mg per day for Day 15 to 28, and then the increased dosage will be
      maintained for Day 29 to 42. Primarily, efficacy will be evaluated by pain intensity using
      numeric rating scale (NRS). Participants' safety will be monitored throughout the study.
    

Intervention name(s): Tramadol hydrochloride/ Acetaminophen; Gabapentin
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 1 tablet containing tramadol HCl 37.5 milligram (mg) and acetaminophen 325 mg once daily, at bed time on Days 1 to 3,. 1 tablet twice daily on Days 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 8 tablets per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42.; Participants will receive Gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg will be administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 3600 mg per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42.
Other intervention name(s): Ultracet
Intervention MeSH terms: Acetaminophen; Gabapentin; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic neuropathy; Ultracet; Tramadol hydrochloride; Acetaminophen; Gabapentin