Neuropathic Pain Management (M-F0434)

January 20, 2014 updated by: Merck KGaA, Darmstadt, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Hidalgo
      • Pachuca, Hidalgo, Mexico, 42090
        • REMEDI Resultados Médicos Desarrollo e Investigación, S.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Visit 3 (Week 1)
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.
Visit 4 (Week 2)
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.
Visit 5 (Week 3)
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.
Visit 6 (Week 4)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Visit 2 (Baseline) to Visit 6 (Week 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

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

Investigators

  • Study Director: Medical Director, Merck S.A. de C.V., Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 17, 2010

First Posted (ESTIMATE)

December 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 13, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200057-500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Neuropathies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe