Official Title: “An Open, Multicenter Study on the Efficacy, Safety and Tolerability of Gabapentin, Titrated for Reaching an Effect for the Treatment of the Painful Diabetic Neuropathy”

The purpose of this study was to evaluate the efficacy, safety, and tolerability of gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of life of all treated patients was also assessed.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: gabapentin
  • Gabapentin oral capsules: Week 0: Day 1: 300 mg; Day 2: 600 mg (2 doses of 300 mg); Day 3: 900 mg (3 doses of 300 mg), maintained until the end of the week; After this point, the total daily dose was divided in 3 equal doses. Week 1: Day 1: 1200 mg; Day 2 to 7: 1800 mg Week 2: Day 1: 2100 mg; Day 2 to 7: 2400 mg Week 3: Day 1: 2700 mg; Day 2 to 7: 3600 mg Weeks 4 to 11: 3600 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Gabapentin group

Primary Measures

• Change from baseline Mean Pain Score
  • Time Frame: Endpoint
    Safety Issue?: No

Secondary Measures

• Change from baseline Mean Pain Score
  • Time Frame: Weekly
    Safety Issue?: No
• Proportion of responding patients
  • Time Frame: Endpoint
    Safety Issue?: No
• Change from baseline Mean Pain Interference with Sleep Score
  • Time Frame: Weekly and Endpoint
    Safety Issue?: No
• Change from baseline in the 5 sub-scores of the McGill Reduced Pain Questionnaire: the sensory score, the affective score, the total score for pain descriptors, a visual analogue scale, and a scale of Present Pain Intensity
  • Time Frame: Endpoint
    Safety Issue?: No
• Global Change Impression from the Patient's Point of View
  • Time Frame: Endpoint
    Safety Issue?: No
• Change from baseline in quality of life
  • Time Frame: Endpoint
    Safety Issue?: No
• Global Change Impression from the Physician's Point of View
  • Time Frame: Endpoint
    Safety Issue?: No

Inclusion Criteria:

• Patients with stable Diabetes Mellitus 1 or 2
• Clinical diagnosis of distal symmetric polyneuropathy with a minimum duration of 8 weeks
• No clinically significant motor deficits
• Pain described according to at least one of the following clinical manifestations: burning, cramps or twinges, thermal or mechanical alodinea

Exclusion Criteria:

• Treatment with any medication that may interfere with the assessment of gabapentin during the study or within 7 days of the adminstration of gabapentin
• Specific systemic diseases or other medical conditions that would interfere with the assessment of gabapentin therapeutic response or safety

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 51 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00644748

Study ID Number: A9451004

ClinicalTrials.gov Identifier: NCT00644748

Health Authority: Brazil: Comissao Nacional de Etica em Pesquisa

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Link to ClinicalStudyResults.org Posting