Phase 3
Completed N=75
Neuropathic Pain Management
Diabetic Neuropathies · Polyneuropathies
Source: ClinicalTrials.gov NCT01263132 ↗
Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Mean Neuropathic Pain Score at Visit 3 (Week 1) — 51.00; 50.70 Units on a Scale
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.
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 | — |
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
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. Informational only — not medical advice.