NCT00641953已完成2 期
A Randomized, Phase II, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Response Study of an Aqueous Topical Formulation of Nitroglycerin, IMX-150, in the Treatment of Pain in Diabetic Peripheral Neuropathy of the Feet
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 7
- 主要终点
- Change from Baseline to endpoint (Day 29) in the average of neuropathic foot daily pain "24 - Hour Average Pain" scores
研究概览
简要总结
The purpose of this study is to compare the effectiveness of two different dose of IMX-150 to that of placebo (non-active) in the treatment of diabetic peripheral neuropathy pain of the feet.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Must have sufficient command and understanding of the English language to complete diaries and questionnaires
- •If female, may not be pregnant or lactating
- •Can be treated on an outpatient basis
- •Has a clinical diagnosis of Type-1 or Type II diabetes with: confirmed diagnosis of diabetic distal symmetrical sensorimotor polyneuropathy and bilateral pain in the feet for at least 3 months.
- •Must have a hemoglobin A1C value of 11% or less that is stable under treatment
- •Agrees to use the test creams as specified for the 4 week period
- •Willing to not use any other medications, including investigational medications, to treat pain symptoms of Diabetic Neuropathy while in study.
排除标准
- •Currently using any nitrate medications
- •Currently using Viagra®, Levitra®, Cialis® or other phosphodiesterase 5 inhibitors medications for erectile dysfunction
- •Currently treated for symptoms of diabetic neuropathy, including but not limited to Lyrica®, Cymbalta® and transcutaneous stimulation
- •Not on a stable dose for at least 4 weeks prior to study screening of other vasodilators required for underlying conditions
- •Know allergy to Nitroglycerin, propylene glycol or common moisturizing creams
- •History of migraine, cluster or vascular headaches, chronic pain with greater pain intensity than the pain of diabetic neuropathy or other chronic pain condition within the region of the diabetic peripheral neuropathy
- •Amputation of more than one toe per foot
- •Neurological disorder or skin condition that may alter local sensation in the feet
- •History of unstable medical problem, clinically significant screening laboratory test or any current medical condition that would contraindicate the administration of the study mediation, interfere with the study evaluations, or interfere with the patient's ability to comply with the study
- •History of drug (including cannabinoid) or alcohol abuse within the past year
- •Cognitive or language difficulties that would impair completion of the pain assessment tool
- •Within the past 3 months, have had either a myocardial infarction, uncontrolled hypotension, or uncontrolled hypertension
- •Participated in a study of any investigational drug within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to Screening
- •Major abdominal, thoracic or vascular surgery within 6 months of the first dose of study medication
- •Open lesions in the area where the cream is to be applied
- •Fertile patients who are unable or unwilling to comply with the contraceptive requirements during the study period
研究组 & 干预措施
B
Experimental
IMX-150(0.6%) 0.5 g topically BID to each foot
干预措施: IMX-150 (Drug)
A
Experimental
IMX-150 (0.3%) 0.5 g topically BID each foot
干预措施: IMX-150 (Drug)
C
Placebo Comparator
Placebo 0.5 g topically BID to each foot for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline to endpoint (Day 29) in the average of neuropathic foot daily pain "24 - Hour Average Pain" scores
时间窗: Weekly average of "24-hour Average Pain"
次要结局
- Change in weekly average sleep disturbance(daily)
研究者
研究点 (7)
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