Neuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Mean Neuropathic Pain Score at Visit 3 (Week 1)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
F0434
干预措施: F0434 (Drug)
Gabapentin
干预措施: Gabapentin (Drug)
结局指标
主要结局
Mean Neuropathic Pain Score at Visit 3 (Week 1)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire(Visit 2 (Baseline) to Visit 6 (Week 4))