Multiple Dose, Double-Blind, Placebo and Active Controlled Study of Pharmacokinetics of Diractin® as Well as Safety and Efficacy for the Treatment of Muscle Soreness

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Muscle Soreness

Intervention / Treatment
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* Drug: Diractin
* Drug: Diractin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>200 mg Ketoprofen | Drug: Diractin<br> <br> |
| Active Comparator: 2<br>100 mg Ketoprofen | Drug: Diractin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, of Diractin®, safety, efficacy, exercise