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

Condition(s) targeted: Diabetic Neuropathies

Intervention: gabapentin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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 design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline Mean Pain Score

Secondary outcome:

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

Minimum age: 51 Years. Maximum age: N/A. Gender(s): Both.

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

Pfizer Investigational Site, FORTALEZA, CEARA 60120-021, Brazil

Pfizer Investigational Site, TAGUATINGA, DF 72119-900, Brazil

Pfizer Investigational Site, CURITIBA, PARANA 80060-150, Brazil

Pfizer Investigational Site, RECIFE, PERNAMBUCO 52051-380, Brazil

Pfizer Investigational Site, RIO DE JANEIRO, RJ 20211-340, Brazil

Pfizer Investigational Site, PORTO ALEGRE, RS, Brazil

Pfizer Investigational Site, Unknown, SAO PAULO, Brazil

Pfizer Investigational Site, SAO PAULO, SP 01246-903, Brazil

Pfizer Investigational Site, SAO PAULO, SP 04020-041, Brazil

Pfizer Investigational Site, BELO HORIZONTE, mg 30150-221, Brazil

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting

Starting date: May 2003
Ending date: August 2004
Last updated: March 31, 2008