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Sponsored by: |
IDEA AG |
Information provided by: | IDEA AG |
ClinicalTrials.gov Identifier: | NCT00745771 |
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 II |
MedlinePlus related topics: | Exercise and Physical Fitness |
Study Type: | Interventional |
Study Design: | 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 |
Enrollment: | 168 |
Study Start Date: | October 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
200 mg Ketoprofen
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Drug: Diractin |
2: Active Comparator
100 mg Ketoprofen
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Drug: Diractin |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Understands nature and provision of the study
Exclusion Criteria:
4.2.1 General Exclusion Criteria
4.2.2 Medical History Related Exclusion Criteria
Responsible Party: | IDEA AG ( Dr. Claudia Himly ) |
Study ID Numbers: | CL-033-II-02 |
First Received: | September 2, 2008 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00745771 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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