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Neuropathic Pain Management (M-F0434)

Primary Purpose

Diabetic Neuropathies, Polyneuropathies

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
F0434
Gabapentin
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies focused on measuring Polyneuropathy, Diabetes Mellitus, Diabetic peripheral neuropathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • REMEDI Resultados Médicos Desarrollo e Investigación, S.C.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

F0434

Gabapentin

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 14, 2010
Last Updated
January 20, 2014
Sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck S.A. de C.V., Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT01263132
Brief Title
Neuropathic Pain Management
Acronym
M-F0434
Official Title
Neuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck S.A. de C.V., Mexico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies, Polyneuropathies
Keywords
Polyneuropathy, Diabetes Mellitus, Diabetic peripheral neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
F0434
Arm Type
Experimental
Arm Title
Gabapentin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
F0434
Other Intervention Name(s)
Gabapentin with thiamine and cobalamin
Intervention Description
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
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Gababion, Gavindo
Intervention Description
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)
Primary Outcome Measure Information:
Title
Mean Neuropathic Pain Score at Visit 3 (Week 1)
Description
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.
Time Frame
Visit 3 (Week 1)
Title
Mean Neuropathic Pain Score at Visit 4 (Week 2)
Description
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.
Time Frame
Visit 4 (Week 2)
Title
Mean Neuropathic Pain Score at Visit 5 (Week 3)
Description
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.
Time Frame
Visit 5 (Week 3)
Title
Mean Neuropathic Pain Score at Visit 6 (Week 4)
Description
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.
Time Frame
Visit 6 (Week 4)
Secondary Outcome Measure Information:
Title
Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire
Description
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.
Time Frame
Visit 2 (Baseline) to Visit 6 (Week 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck S.A. de C.V., Mexico
Official's Role
Study Director
Facility Information:
Facility Name
REMEDI Resultados Médicos Desarrollo e Investigación, S.C.
City
Pachuca
State/Province
Hidalgo
ZIP/Postal Code
42090
Country
Mexico

12. IPD Sharing Statement

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