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Neuropathic Pain Management (M-F0434)

This study has been completed.
Sponsor:
Collaborator:
Merck S.A. de C.V., Mexico
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01263132
First received: December 14, 2010
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
  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.


Condition Intervention Phase
Diabetic Neuropathies
Polyneuropathies
 Drug: F0434
Drug: Gabapentin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Neuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Mean Neuropathic Pain Score at Visit 3 (Week 1) [ Time Frame: Visit 3 (Week 1) ] [ Designated as safety issue: Yes ]
    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.

  • Mean Neuropathic Pain Score at Visit 4 (Week 2) [ Time Frame: Visit 4 (Week 2) ] [ Designated as safety issue: Yes ]
    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.

  • Mean Neuropathic Pain Score at Visit 5 (Week 3) [ Time Frame: Visit 5 (Week 3) ] [ Designated as safety issue: Yes ]
    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.

  • Mean Neuropathic Pain Score at Visit 6 (Week 4) [ Time Frame: Visit 6 (Week 4) ] [ Designated as safety issue: Yes ]
    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.


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.


Enrollment: 104
Study Start Date: February 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: F0434 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 Name: Gabapentin with thiamine and cobalamin
Active Comparator: Gabapentin 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)
Other Names:
  • Gababion
  • Gavindo

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263132

Locations
Mexico
REMEDI Resultados Médicos Desarrollo e Investigación, S.C.
Pachuca, Hidalgo, Mexico, 42090
Sponsors and Collaborators
Merck KGaA
Merck S.A. de C.V., Mexico
Investigators
Study Director: Medical Director Merck S.A. de C.V., Mexico
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01263132     History of Changes
Other Study ID Numbers: 200057-500
Study First Received: December 14, 2010
Results First Received: September 19, 2011
Last Updated: September 19, 2011
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Merck KGaA:
Polyneuropathy
Diabetes Mellitus
Diabetic peripheral neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Neuralgia
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 22, 2013