EUCTR2007-002581-35-DE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 soreness
IDEA AG0 个研究点目标入组 168 人开始时间: 2007年7月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 168
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •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)
- •Muscle soreness with a pain score of at least 3 on a 10 point categorical pain scale at 12-16h after exercise
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
- •Not willing to refrain from exposing target areas after treatment to
- •excessive ultraviolet light (solar radiation or solarium)
- •Pregnancy or lactation
- •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
- •Blood donation one month before screening and during the study
- •Asthma bronchiale
- •Medication during the study observation period (Screening to final Visit) containing
- •oGlucocorticoids
- •oProbenecid
- •oSulfinpyrazon
- •Diuretics during the study observation period (Screening to final Visit)
- •ACE inhibitors during the study observation period (Screening to final Visit)
- •Anticoagulants during the study observation period (Screening to final Visit)
- •Methotrexat during the study observation period (Screening to final Visit)
- •Antacids during the study observation period (Screening to final Visit)
研究者
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