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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00644748

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

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

ClinicalTrials.gov processed this record on February 09, 2012