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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gabapentin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Mean Pain Score | Endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Mean Pain Score | Weekly | |
| Proportion of responding patients | Endpoint | |
| Change from baseline Mean Pain Interference with Sleep Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Fortaleza | Ceará | 60120-021 | Brazil | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
| Weekly and Endpoint |
| 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 |
| Global Change Impression from the Patient's Point of View | Endpoint |
| Change from baseline in quality of life | Endpoint |
| Global Change Impression from the Physician's Point of View | Endpoint |
| Taguatinga |
| Federal District |
| 72119-900 |
| Brazil |
| Pfizer Investigational Site | Belo Horizonte | Minas Gerais | 30150-221 | Brazil |
| Pfizer Investigational Site | Curitiba | Paraná | 80060-150 | Brazil |
| Pfizer Investigational Site | Recife | Pernambuco | 52051-380 | Brazil |
| Pfizer Investigational Site | Rio de Janeiro | Rio de Janeiro | 20211-340 | Brazil |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01246-903 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04020-041 | Brazil |
| Pfizer Investigational Site |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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