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

This study has been completed.
Sponsor:
Information provided by:
IDEA AG
ClinicalTrials.gov Identifier:
NCT00745771
First received: September 2, 2008
Last updated: March 19, 2009
Last verified: March 2009
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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
Active Comparator: 1
200 mg Ketoprofen
Drug: Diractin
Active Comparator: 2
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
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: Ingrid Patzak, IDEA AG
ClinicalTrials.gov Identifier: NCT00745771     History of Changes
Other Study ID Numbers: CL-033-II-02
Study First Received: September 2, 2008
Last Updated: March 19, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by IDEA AG:
pharmacokinetics
of Diractin®
safety
efficacy
exercise

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

ClinicalTrials.gov processed this record on April 17, 2014