Neuropathic Pain Management
Overview[ - collapse ][ - ]
Purpose | This is a prospective, randomized, double blind, comparative, experimental controlled Phase 3 clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with chronic distal diabetic polyneuropathy. |
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Condition | Diabetic Neuropathies Polyneuropathies |
Intervention | Drug: F0434 Drug: Gabapentin |
Phase | Phase 3 |
Sponsor | Merck KGaA |
Responsible Party | Merck KGaA |
ClinicalTrials.gov Identifier | NCT01263132 |
First Received | December 14, 2010 |
Last Updated | January 20, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | December 14, 2010 |
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Last Updated Date | January 20, 2014 |
Start Date | February 2008 |
Estimated Primary Completion Date | February 2010 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire [Time Frame: Visit 2 (Baseline) to Visit 6 (Week 4)] [Designated as safety issue: Yes]SF-36 is a standardized health survey consisting of 36 questions to measure functional health status. Summary scores are calculated using the following 8 dimensions: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is obtained by SF-36 algorithm and it is represented as an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). Higher scores are indicative of a better health status. |
Descriptive Information[ + expand ][ + ]
Brief Title | Neuropathic Pain Management |
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Official Title | Neuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study |
Brief Summary | This is a prospective, randomized, double blind, comparative, experimental controlled Phase 3 clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with chronic distal diabetic polyneuropathy. |
Detailed Description | Subjects will be assigned to one of the two arms of the study, after having been deemed eligible during the screening visit in random double-blind design. Subjects will be evaluated for a 4 week period. OBJECTIVES - To assess the effects of F0434 and gabapentin alone on neuropathic pain and Quality Of Life (QOL) of subjects with diabetic neuropathy through a current and validated neuropathic pain scale along with the QOL questionnaire. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition |
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Intervention | Drug: F0434 F0434 will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2). Other Names: Gabapentin with thiamine and cobalaminDrug: Gabapentin Gabapentin will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2) Other Names:
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Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 104 |
Estimated Completion Date | February 2010 |
Estimated Primary Completion Date | February 2010 |
Eligibility Criteria | Inclusion Criteria: - Subjects diagnosed with diabetes mellitus type 2 - Subjects with a history of neuropathic pain in the last 3 Months - Men and women in reproductive age with a family planning method - Subjects aged between 18 to 70 years - Subjects with glycosylated haemoglobin (HbA1c) greater than 7% and less than 15% - Subjects that obtain a grade equal or greater than 4 in the visual analogue scale during the screening visit Exclusion Criteria: - Subjects diagnosed as being pregnant or in state of lactation - Subjects with serum creatinine greater than 1.2 or creatinine depuration in 24 hour urine, less than 60mL/min - Subjects who are receiving treatment with anti-depressants, anti-epileptics, and are taking vitamin B1 and B12 for treatment of neuropathic diabetes - Subjects who are being pharmacologically treated for epilepsy - Subjects diagnosed with rheumatic and hepatic disease and diagnosed with neuropathy for other causes - Subjects with psychological and psychiatric alteration that hinders adequate collaboration in the study - Subjects with any orthopaedic alteration of any extremity - Subjects with peripheral artery disease - Subjects taking more than two neuropathic pain medicines - Subjects with history of alcohol, cocaine, marijuana or benzodiazepine substance abuse - Subjects with acid-peptic disease - Subjects with history of neoplasm of any type |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Mexico |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01263132 |
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Other Study ID Numbers | 200057-500 |
Has Data Monitoring Committee | No |
Information Provided By | Merck KGaA |
Study Sponsor | Merck KGaA |
Collaborators | Merck S.A. de C.V., Mexico |
Investigators | Study Director: Medical Director Merck S.A. de C.V., Mexico |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
REMEDI Resultados Médicos Desarrollo e Investigación, S.C. | Pachuca, Hidalgo, Mexico, 42090 |
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