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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: IDEA AG

Criteria

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