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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00745771
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : March 20, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Muscle Soreness Drug: Diractin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Primary Purpose: 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
Study Start Date : October 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : November 2008

Arm Intervention/treatment
Active Comparator: 1
200 mg Ketoprofen
Drug: Diractin
Active Comparator: 2
100 mg Ketoprofen
Drug: Diractin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00745771

X-pert Med GmbH
Jena, Thüringen, Germany, 07745
Sponsors and Collaborators
Principal Investigator: Egbert Seidel, MD X-pert Med Jena

Responsible Party: Ingrid Patzak, IDEA AG Identifier: NCT00745771     History of Changes
Other Study ID Numbers: CL-033-II-02
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: March 20, 2009
Last Verified: March 2009

Keywords provided by IDEA AG:
of Diractin®

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms