Status:
COMPLETED
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
Lead Sponsor:
IDEA AG
Conditions:
Muscle Soreness
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00745771
Start Date
October 1 2007
End Date
November 1 2008
Last Update
March 20 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
X-pert Med GmbH
Jena, Thuringia, Germany, 07745