NCT00372333已完成3 期
A Multiple-Dose, Open-Label Safety, Compliance, and Usage Evaluation Study of Epicutaneously Applied IDEA-033 in Joint / Musculoskeletal Pain or Soft Tissue Inflammation
IDEA AG2 个研究点 分布在 1 个国家目标入组 491 人开始时间: 2004年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 491
- 试验地点
- 2
- 主要终点
- description of AE profile
研究概览
简要总结
The main aim of the study is to evaluate safety, efficacy, compliance, and usage of epicutaneously applied IDEA-033 in joint / musculoskeletal pain or soft tissue inflammation.
详细描述
Multi-centre, one arm, multiple dose, open-label, at home usage study. Adult volunteers experiencing joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation will be screened for study participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years or older
- •agree to refrain from chronic usage of NSAIDs or any other analgesics or anti-inflammatory drugs other than those provided during the course of the study or documented sporadic concomitant analgesics
- •joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation in designated target area(s) that are appropriate for self-treatment with a topical analgesic or where availability of a second person can be guaranteed in case self-treatment is not possible
- •healthy skin in the target area(s)
排除标准
- •known hypersensitivity to IDEA-033 or other NSAIDs
- •history of coagulation disorders
- •history of peptic ulcers or gastric intolerance with NSAIDs
- •urinary tract infection
- •clinically significant renal, hepatic, or gastric disease
- •acute or chronic coexisting illness qualifying for exclusion according to clinical judgement of the investigator
- •clinical laboratory values outside normal range deemed clinically significant by the investigator
- •Narcotics-containing products within 7 days of administering IMP
- •Malignancy within the past 2 years
结局指标
主要结局
description of AE profile
changes in laboratory values
IDEA-033 plasma levels
visual assessment of skin at target area(s)
physical exam
vital signs
次要结局
- evaluation of efficacy by real time feedback
研究者
研究点 (2)
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