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 - Full Text View

Sponsored by:	IDEA AG
Information provided by:	IDEA AG
ClinicalTrials.gov Identifier:	NCT00745771

Purpose

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.

Condition	Intervention	Phase
Muscle Soreness	Drug: Diractin	Phase II

Study Type:	Interventional
Study Design:	Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by IDEA AG:

Enrollment:	168
Study Start Date:	October 2007
Study Completion Date:	November 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 200 mg Ketoprofen	Drug: Diractin
2: Active Comparator 100 mg Ketoprofen	Drug: Diractin

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745771

Locations

Germany, Thüringen
X-pert Med GmbH
Jena, Thüringen, Germany, 07745

Sponsors and Collaborators

IDEA AG

Investigators

Principal Investigator:

Egbert Seidel, MD

X-pert Med Jena

More Information

No publications provided

Responsible Party:	IDEA AG ( Ingrid Patzak )
Study ID Numbers:	CL-033-II-02
Study First Received:	September 2, 2008
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00745771 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by IDEA AG:

pharmacokinetics
of Diractin®
safety
efficacy
exercise

ClinicalTrials.gov processed this record on September 10, 2009