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
Intervention: Tramadol hydrochloride/ Acetaminophen; Gabapentin
Intervention description: 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.
Intervention MeSH terms: Acetaminophen; Gabapentin; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetic neuropathy; Ultracet; Tramadol hydrochloride; Acetaminophen; Gabapentin

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants having painful symmetric neuropathy (a disturbance in the function of the
             brain or spinal cord that may affect the nerves and muscles of the body) in the lower
             limbs applicable to both of the following conditions: decreased sensation of leg to
             monofilament, none or decreased ankle reflexes or decreased vibratory sensation and
             pain symptoms such as numbness (loss of sensation), tingling, paresthesia (a skin
             sensation, such as burning, prickling, itching, or tingling, with no apparent physical
             cause), burning, shooting pain, stabbing or lancinating (characterized by a sensation
             of cutting, piercing, or stabbing) pain

          -  Participants having painful diabetic neuropathy in the lower limbs for 3 months before
             randomization

          -  Participants diagnosed with Type ll diabetes and stable blood sugar level controlled
             with an oral medication, insulin or diet therapy for 3 months before randomization

          -  Participants with glycated hemoglobin (HbA1c) less than or equal to 10 percent

          -  Participants with pain intensity score of greater than or equal to 4 on numeric rating
             scale (NRS) for the last 48 hours

        Exclusion Criteria:

          -  Participants who have previously experienced failure of tramadol treatment or have
             discontinued tramadol administration due to adverse event

          -  Participants who have received the prohibited medication before randomization (e.g.,
             capsaicin, use of systemic steroids, steroid or local anesthetic injections, tramadol
             HCl or tramadol combination, gabapentin, opioid analgesics, antidepressants,
             anticonvulsants, alpha-lipoic acid, acupuncture, COX-2 selective inhibitors,
             long-acting NSAIDs, opioid analgesics, sedative-hypnotics, muscle relaxants,
             anxiolytics, antipsychotics, TENS, short-acting non-opioid analgesics)

          -  Participants with neuropathic pain caused by other reasons (e.g., alcohol abuse,
             connective tissue disease, toxic exposure, infection, neoplasm, ischemia)

          -  Participants suffering from painful diabetic neuropathy over 10 years

          -  Participants with physical damage or disease which may cause abnormal absorption,
             excessive accumulation, metabolism or excretion disorder of the study medication