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

Primary Purpose

Diabetic Neuropathies

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
gabapentin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies

Eligibility Criteria

51 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gabapentin group

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline Mean Pain Score

Secondary Outcome Measures

Change from baseline Mean Pain Score
Proportion of responding patients
Change from baseline Mean Pain Interference with Sleep Score
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
Global Change Impression from the Patient's Point of View
Change from baseline in quality of life
Global Change Impression from the Physician's Point of View

Full Information

First Posted
March 25, 2008
Last Updated
February 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00644748
Brief Title
A Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
gabapentin
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline Mean Pain Score
Time Frame
Endpoint
Secondary Outcome Measure Information:
Title
Change from baseline Mean Pain Score
Time Frame
Weekly
Title
Proportion of responding patients
Time Frame
Endpoint
Title
Change from baseline Mean Pain Interference with Sleep Score
Time Frame
Weekly and Endpoint
Title
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
Title
Global Change Impression from the Patient's Point of View
Time Frame
Endpoint
Title
Change from baseline in quality of life
Time Frame
Endpoint
Title
Global Change Impression from the Physician's Point of View
Time Frame
Endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60120-021
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Taguatinga
State/Province
DF
ZIP/Postal Code
72119-900
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80060-150
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
52051-380
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20211-340
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-903
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04020-041
Country
Brazil
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9451004&StudyName=A%20study%20on%20the%20efficacy%20and%20safety%20of%20gabapentin%20in%20the%20treatment%20of%20patients%20with%20painful%20diabetic%20neuropathy
Description
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Learn more about this trial

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

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