Clinical trial NCT01263132: Neuropathic Pain Management
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Neuropathies
Polyneuropathies
Keywords: Polyneuropathy
Diabetes Mellitus
Diabetic peripheral neuropathy
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck S.A. de C.V., Mexico
First posted: 2010-12-20
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Neuropathic Pain Score at Visit 3 (Week 1)
timeFrame: Visit 3 (Week 1)
measure: Mean Neuropathic Pain Score at Visit 4 (Week 2)
timeFrame: Visit 4 (Week 2)
measure: Mean Neuropathic Pain Score at Visit 5 (Week 3)
timeFrame: Visit 5 (Week 3)
measure: Mean Neuropathic Pain Score at Visit 6 (Week 4)
timeFrame: Visit 6 (Week 4)
Secondary outcomes:
measure: Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire
timeFrame: Visit 2 (Baseline) to Visit 6 (Week 4)
Other outcomes:
Locations:
city: Pachuca
country: Mexico
facility: REMEDI Resultados Médicos Desarrollo e Investigación, S.C.
state: Hidalgo
Study officials:
affiliation: Merck S.A. de C.V., Mexico
name: Medical Director
role: STUDY_DIRECTOR
References: