Neuropathic Pain Management

NCT01263132 | Completed Phase 3 Results

• 1 other identifier: 200057-500
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathies; Polyneuropathies

Keywords

Polyneuropathy; Diabetes Mellitus; Diabetic peripheral neuropathy

Outcome Measures

Primary Outcomes (4)

• Mean Neuropathic Pain Score at Visit 3 (Week 1)

  Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.

  Visit 3 (Week 1)

• Mean Neuropathic Pain Score at Visit 4 (Week 2)

  Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.

  Visit 4 (Week 2)

• Mean Neuropathic Pain Score at Visit 5 (Week 3)

  Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.

  Visit 5 (Week 3)

• Mean Neuropathic Pain Score at Visit 6 (Week 4)

  Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.

  Visit 6 (Week 4)

Secondary Outcomes (1)

• Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire

  Visit 2 (Baseline) to Visit 6 (Week 4)

Study Arms (2)

F0434

EXPERIMENTAL

Drug: F0434

Gabapentin

ACTIVE COMPARATOR

Drug: Gabapentin

Interventions

F0434 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).

Also known as: Gabapentin with thiamine and cobalamin

F0434

Gabapentin 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)

Also known as: Gababion, Gavindo

Gabapentin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck S.A. de C.V., Mexico: collaborator

Study Sites (1)

REMEDI Resultados Médicos Desarrollo e Investigación, S.C.

Pachuca, Hidalgo, 42090, Mexico

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Polyneuropathies; Diabetes Mellitus

Interventions

Gabapentin; Thiamine; Vitamin B 12

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Corrinoids; Tetrapyrroles; Pyrroles; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Medical Responsible
• Organization: Merck S.A. de C.V., Mexico, an affiliate of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Director

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 20, 2010
• Study Start: February 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 13, 2014
• Results First Posted: October 27, 2011

Record last verified: 2014-01

Locations

ME (1)