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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 18, 2014