- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00745771
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
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL-033-II-02
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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