Neuropathic Pain Management

NCT ID: NCT01263132

Last Updated: 2014-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-02-28

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.

Conditions

Diabetic Neuropathies; Polyneuropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

F0434

Group Type: EXPERIMENTAL

F0434

Intervention Type: DRUG

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).

Gabapentin

Group Type: ACTIVE_COMPARATOR

Gabapentin

Intervention Type: DRUG

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)

Interventions

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).

Intervention Type: DRUG

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)

Intervention Type: DRUG

Other Intervention Names

Gabapentin with thiamine and cobalamin; Gababion; Gavindo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck S.A. de C.V., Mexico

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck S.A. de C.V., Mexico

Locations

REMEDI Resultados Médicos Desarrollo e Investigación, S.C.

Pachuca, Hidalgo, Mexico

Countries

Mexico

Other Identifiers

200057-500

Identifier Type: -

Identifier Source: org_study_id