A Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy
NCT00644748
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | A Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Diabetic Neuropathies | |||
Intervention ICMJE | 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 | |||
Study Arms ICMJE | Experimental: Gabapentin group
Intervention: Drug: gabapentin | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 95 | |||
Original Estimated Enrollment ICMJE | 100 | |||
Actual Study Completion Date ICMJE | August 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 51 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Brazil | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00644748 | |||
Other Study ID Numbers ICMJE | A9451004 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | October 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |