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

Diabetic Neuropathies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644748
• Other study ID #: A9451004
• Status: Completed
• Phase: Phase 4
• Start date: May 2003
• Est. completion date: August 2004

Study information

• Verified date: October 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 51 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies

Intervention

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

Locations

Country	Name	City	State
	Pfizer Investigational Site
Brazil	Pfizer Investigational Site	Belo Horizonte	MG
Brazil	Pfizer Investigational Site	Curitiba	Parana
Brazil	Pfizer Investigational Site	Fortaleza	Ceara
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Recife	Pernambuco
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Taguatinga	DF

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Mean Pain Score		Endpoint
Secondary	Change from baseline Mean Pain Score		Weekly
Secondary	Proportion of responding patients		Endpoint
Secondary	Change from baseline Mean Pain Interference with Sleep Score		Weekly and Endpoint
Secondary	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		Endpoint
Secondary	Global Change Impression from the Patient's Point of View		Endpoint
Secondary	Change from baseline in quality of life		Endpoint
Secondary	Global Change Impression from the Physician's Point of View		Endpoint

External Links

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