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Completed

NCT Number: NCT01263132

Neuropathic Pain Management

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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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Polyneuropathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

REMEDI Resultados Médicos Desarrollo e Investigación, S.C.

Pachuca, Hidalgo, 42090, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Gabapentin with thiamine and cobalamin

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)

Other names: Gababion, Gavindo

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: Visit 2 (Baseline) to Visit 6 (Week 4)

    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.

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck S.A. de C.V., Mexico

Registry information

Official study title

Neuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study

Acronym: M-F0434

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 20, 2010
Registry last updated
Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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