Phase 3 N=75 Randomized Double-blind Treatment

Neuropathic Pain Management

Diabetic Neuropathies · Polyneuropathies

Bottom Line

View on ClinicalTrials.gov: NCT01263132 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2011

Primary outcome: Primary: Mean Neuropathic Pain Score at Visit 3 (Week 1) — 51.00; 50.70 Units on a Scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: F0434 (Drug); Gabapentin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck KGaA, Darmstadt, Germany
Primary completion: Feb 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Neuropathic Pain Score at Visit 3 (Week 1)	51.00; 50.70	—
PRIMARY Mean Neuropathic Pain Score at Visit 4 (Week 2)	41.24; 36.94	—
PRIMARY Mean Neuropathic Pain Score at Visit 5 (Week 3)	33.74; 24.86	—
PRIMARY Mean Neuropathic Pain Score at Visit 6 (Week 4)	22.08; 17.29	—
SECONDARY Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire	53.044; 56.507; 65.779; 65.610; 69.531; 74.370	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01263132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.