A Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy

February 1, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Pfizer Investigational Site
  • Brazil
    • Ceara
      • Fortaleza, Ceara, Brazil, 60120-021
        • Pfizer Investigational Site
    • DF
      • Taguatinga, DF, Brazil, 72119-900
        • Pfizer Investigational Site
    • MG
      • Belo Horizonte, MG, Brazil, 30150-221
        • Pfizer Investigational Site
    • Parana
      • Curitiba, Parana, Brazil, 80060-150
        • Pfizer Investigational Site
    • Pernambuco
      • Recife, Pernambuco, Brazil, 52051-380
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20211-340
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brazil
        • Pfizer Investigational Site
    • SP
      • Sao Paulo, SP, Brazil, 01246-903
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 04020-041
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gabapentin group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline Mean Pain Score
Time Frame: Endpoint
Endpoint

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline Mean Pain Score
Time Frame: Weekly
Weekly
Proportion of responding patients
Time Frame: Endpoint
Endpoint
Change from baseline Mean Pain Interference with Sleep Score
Time Frame: Weekly and Endpoint
Weekly and Endpoint
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
Endpoint
Global Change Impression from the Patient's Point of View
Time Frame: Endpoint
Endpoint
Change from baseline in quality of life
Time Frame: Endpoint
Endpoint
Global Change Impression from the Physician's Point of View
Time Frame: Endpoint
Endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9451004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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