Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00644748
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : October 10, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Drug: gabapentin Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2003
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Change from baseline Mean Pain Score [ Time Frame: Endpoint ]

Secondary Outcome Measures :
  1. Change from baseline Mean Pain Score [ Time Frame: Weekly ]
  2. Proportion of responding patients [ Time Frame: Endpoint ]
  3. Change from baseline Mean Pain Interference with Sleep Score [ Time Frame: Weekly and Endpoint ]
  4. 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 ]
  5. Global Change Impression from the Patient's Point of View [ Time Frame: Endpoint ]
  6. Change from baseline in quality of life [ Time Frame: Endpoint ]
  7. Global Change Impression from the Physician's Point of View [ Time Frame: Endpoint ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   51 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00644748

Layout table for location information
Pfizer Investigational Site
Fortaleza, Ceara, Brazil, 60120-021
Pfizer Investigational Site
Taguatinga, DF, Brazil, 72119-900
Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30150-221
Pfizer Investigational Site
Curitiba, Parana, Brazil, 80060-150
Pfizer Investigational Site
Recife, Pernambuco, Brazil, 52051-380
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 20211-340
Pfizer Investigational Site
Porto Alegre, RS, Brazil
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 01246-903
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04020-041
Sponsors and Collaborators
Layout table for investigator information
Study Director: Pfizer Call Center Pfizer

Additional Information:
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00644748    
Other Study ID Numbers: A9451004
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: October 10, 2008
Last Verified: October 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents