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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00644748
First received: March 25, 2008
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Diabetic Neuropathies
Drug: gabapentin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline Mean Pain Score [ Time Frame: Endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline Mean Pain Score [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Proportion of responding patients [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • Change from baseline Mean Pain Interference with Sleep Score [ Time Frame: Weekly and Endpoint ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Global Change Impression from the Patient's Point of View [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • Change from baseline in quality of life [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • Global Change Impression from the Physician's Point of View [ Time Frame: Endpoint ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: May 2003
Study Completion Date: August 2004
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   51 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644748

Locations
Brazil
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
Unknown, Sao Paulo, Brazil
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 01246-903
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04020-041
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00644748     History of Changes
Other Study ID Numbers: A9451004
Study First Received: March 25, 2008
Last Updated: October 9, 2008
Health Authority: Brazil: Comissao Nacional de Etica em Pesquisa

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on September 16, 2014