A Randomized 4-week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Pain Due to Diabetic Polyneuropathy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 22
- 主要终点
- Change in mean daily pain intensity score
研究概览
简要总结
The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 18 to 75 years old.
- •Type 1 or type 2 diabetes.
- •Painful DPN symptoms and signs for at least 3 months.
- •Blood glucose controlled with medication.
- •Glycosylated hemoglobin not greater than 9.5 or 11%, country dependent.
- •Prior analgesic medication.
- •Average score of 4 or greater on the 11 point NRS during the last 3 days prior to randomization.
排除标准
- •Impaired liver, cardiac or renal function.
- •Breastfeeding and pregnancy.
- •History of substance abuse, alcohol or medication.
- •Chronic gastrointestinal disease.
- •History of seizures and or epilepsy.
- •History or presence of malignancy.
- •Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis.
- •Allergies to opioids, acetaminophen or excipients of the medications.
研究组 & 干预措施
25 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day
干预措施: GRT6005 (Drug)
75 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day
干预措施: GRT6005 (Drug)
200 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day
干预措施: GRT6005 (Drug)
Matching Placebo
Participants allocated to this treatment arm will receive a dose of matched placebo once a day.
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Change in mean daily pain intensity score
时间窗: Baseline to Week 4
Participants will be selected based on their medical history and clinical examination. Efficacy of the treatment (i.e., reduction of pain) will be evaluated with the 11-point numeric rating scale (NRS), where 0 represents no pain and 10 represents "pain as bad as you can imagine".
次要结局
- Neuropathic Pain Scale, changes from baseline(End of 4 weeks)
- Response measured in percentage change of pain intensity from baseline(End of 4 Weeks)
- Changes in Quantitative Sensory Testing from baseline(Baseline, week 1 and week 4)
- Leeds Sleep Evaluation Questionnaire(End of treatment)
- Quality of Life Index -Short-Form-12®, from baseline(End of treatment)
- Patient's Global Impression of Change(End of treatment)
- Quality of Life EuroQoL-5 Dimension score, change from baseline(End of 4 weeks)
- Short Form of the Brief Pain Inventory, changes from baseline(End of 4 weeks)
- Rescue medication use(End of 4 weeks)
- Clinical Opioid Withdrawal Scale(End of 4 weeks)
- Plasma concentration(End of 4 weeks)