An Efficacy and Safety Study of Carisbamate in the Treatment of Nerve Pain in Diabetics

Sponsor
SK Life Science, Inc.
Study ID
NCT00870454
Phase
PHASE2
Status
Completed

Conditions

  • Diabetic Neuropathies

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pregabalin 300 mg/d — DRUG
    75 mg/d twice daily for Week 1, followed by 150 mg twice daily for the remainder
  • Carisbamate 800 mg/d — DRUG
    200 mg/d twice daily, titrated up to 400 mg twice daily, as tolerated, by Week 3
  • Carisbamate 1,200 mg/d — DRUG
    200 mg/d twice daily, titrated up to 600 mg twice daily, as tolerated, by Week 3
  • Placebo — DRUG
    Placebo capsules twice daily

Study Details

The purpose of this study is to evaluate the safety, tolerability, and efficacy of carisbamate (800 and 1200 mg/day) in patients with diabetic neuropathic pain.

Key Dates

Start date
May 31, 2009
Status verified
Jan 2013
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
386 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 001
    Carisbamate 800 mg/d 200 mg/d twice daily titrated up to 400 mg twice daily as tolerated by Week 3
  • Experimental: 002
    Carisbamate 1 200 mg/d 200 mg/d twice daily titrated up to 600 mg twice daily as tolerated by Week 3
  • Active Comparator: 003
    Pregabalin 300 mg/d 75 mg/d twice daily for Week 1 followed by 150 mg twice daily for the remainder
  • Placebo Comparator: 004
    Placebo Placebo capsules twice daily

Primary Outcome Measure

Mean of the last 7 daily average diabetic peripheral neuropathy (DPN) pain scores [ Time Frame: Through 15 weeks ]

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