NCT00745771已完成2 期
Multiple Dose, Double-Blind, Double-Dummy, Placebo and Active Controlled Study of Pharmacokinetics of Diractin® as Well as Safety and Efficacy for the Treatment of Muscle Soreness From Exercise
IDEA AG1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
研究概览
简要总结
Multiple-dose, double-blind, double-dummy, parallel, randomized, placebo and active controlled study of pharmacokinetics of Diractin® as well as safety and efficacy for muscle soreness from exercise.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Understands nature and provision of the study
- •Have been informed about the study by the investigator and gave signed and dated informed consent prior to participation
- •Muscle soreness with a pain score of at least 3 on a 10 point categorical pain scale at 12-16h after exercise
- •Male and female subjects
- •Age 18-55 years
- •Subjects in good health as determined by the Investigator
- •Woman of childbearing potential using reliable methods of contraception with a low failure rate (i.e. less than 1% per year), e.g. implants, injectables, combined oral contraceptives, reliable intrauterine-devices, vasectomised/ infertile partner or surgically sterile (uterus removed or both tubes tied) or postmenopausal (at least 2 years without periods)
排除标准
- •4.2.1 General Exclusion Criteria
- •Investigator or any other team member involved directly or indirectly in the conduct of the clinical trial
- •Subjects who are inmates of psychiatric wards, prisons, or other state institutions
- •Participation in another clinical trial within the last 30 days and during the study
- •Not willing to refrain from exposing target areas after treatment to excessive ultraviolet light (solar radiation or solarium)
- •Pregnancy or lactation
- •4.2.2 Medical History Related Exclusion Criteria
- •History of dermal allergic reactions
- •Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen, and ingredients used in pharmaceutical products
- •Alcohol or drug abuse
- •Malignancy within the past 2 years
- •Skin lesions, dermatological diseases or tattoo in the treatment area
- •Major surgery 3 months before enrolment
- •NSAID idiosyncrasy
- •Impaired haematopoesis and coagulation
- •Gastric and duodenal ulcer and gastrointestinal bleedings
- •Systemic lupus erythematodes, mixed connective tissue disease
- •Major heart disease / uncontrolled hypertension
- •Hepatic failure with ALT and/or AST > 2.0 ULN
- •Renal failure with serum creatinine levels > 1.5 milligrams/deciliter (mg/dL)
- •Varicosis, thrombophlebitis and other vascular disorders of the lower extremities
- •Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-sceletal system of the lower limbs
- •HIV - Infection
- •Hepatitis B or C
- •Asthma bronchiale
- •Blood donation one month before screening and during study
研究组 & 干预措施
1
Active Comparator
200 mg Ketoprofen
干预措施: Diractin (Drug)
2
Active Comparator
100 mg Ketoprofen
干预措施: Diractin (Drug)
研究者
研究点 (1)
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进行中（未招募）
不适用
Multiple dose, double-blind, double-dummy, placebo and active controlled study of pharmacokinetics of Diractin® as well as safety and efficacy for the treatment of muscle soreness from exercise - Pharmacokinetic of Diractin and effect on muscle sorenessThe study population is a healthy population who are voluntarily participating in this clinical trial. This study will compare the PK profile after e.c. and oral application of the same dosage of ketoprofen and in a dosage range as intended for clinical use in OA. It will also indicate whether application on muscle will result in a different PK profile as compared to application on a joint.The intended use for Diractin® will be osteoarthritis of the kneeMedDRA version: 9.1Level: LLTClassification code 10028332Term: Muscle sorenessEUCTR2007-002581-35-DEIDEA AG168
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