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

March 19, 2009 updated by: IDEA AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
200 mg Ketoprofen
Active Comparator: 2
100 mg Ketoprofen

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Egbert Seidel, MD, X-pert Med Jena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Estimate)

March 20, 2009

Last Update Submitted That Met QC Criteria

March 19, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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