Muscle Soreness Clinical Trial
Official title:
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
Verified date | March 2009 |
Source | IDEA AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 168 |
Est. completion date | November 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | X-pert Med GmbH | Jena | Thüringen |
Lead Sponsor | Collaborator |
---|---|
IDEA AG |
Germany,
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