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

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00644748
• Collaborator: (none)
• Enrollment: 95
• Locations: 10
• Arm: 1
• Duration (Months): 15
• Patients Per Site: 9.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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 1, 2003
• Actual Study Completion Date: Aug 1, 2004

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline Mean Pain Score [Endpoint]

Secondary Outcome Measures

1. Change from baseline Mean Pain Score [Weekly]

2. Proportion of responding patients [Endpoint]

3. Change from baseline Mean Pain Interference with Sleep Score [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 [Endpoint]

5. Global Change Impression from the Patient's Point of View [Endpoint]

6. Change from baseline in quality of life [Endpoint]

7. Global Change Impression from the Physician's Point of View [Endpoint]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 51 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Fortaleza	Ceara	Brazil	60120-021
2	Pfizer Investigational Site	Taguatinga	DF	Brazil	72119-900
3	Pfizer Investigational Site	Belo Horizonte	MG	Brazil	30150-221
4	Pfizer Investigational Site	Curitiba	Parana	Brazil	80060-150
5	Pfizer Investigational Site	Recife	Pernambuco	Brazil	52051-380
6	Pfizer Investigational Site	Rio de Janeiro	RJ	Brazil	20211-340
7	Pfizer Investigational Site	Porto Alegre	RS	Brazil
8	Pfizer Investigational Site	Sao Paulo	SP	Brazil	01246-903
9	Pfizer Investigational Site	Sao Paulo	SP	Brazil	04020-041
10	Pfizer Investigational Site

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00644748
• Other Study ID Numbers: A9451004
• First Posted: Mar 27, 2008
• Last Update Posted: Feb 2, 2021
• Last Verified: Oct 1, 2008

• Additional relevant MeSH terms: Diabetic Neuropathies; Gabapentin

Study Results

No Results Posted as of Feb 2, 2021