Neuropathic Pain Management

Diabetic Neuropathies Clinical Trial

— M-F0434  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263132
• Other study ID #: 200057-500
• Status: Completed
• Phase: Phase 3
• First received: December 14, 2010
• Last updated: January 20, 2014
• Start date: February 2008
• Est. completion date: February 2010

Study information

• Verified date: January 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuralgia
• Polyneuropathies

Intervention

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).
• 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)

Locations

Country	Name	City	State
Mexico	REMEDI Resultados Médicos Desarrollo e Investigación, S.C.	Pachuca	Hidalgo

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck S.A. de C.V., Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Secondary	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.	Visit 2 (Baseline) to Visit 6 (Week 4)	Yes