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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00745771
Other study ID # CL-033-II-02
Secondary ID
Status Completed
Phase Phase 2
First received September 2, 2008
Last updated March 19, 2009
Start date October 2007
Est. completion date November 2008

Study information

Verified date March 2009
Source IDEA AG
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date November 2008
Est. primary completion date February 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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 Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Diractin

Diractin


Locations

Country Name City State
Germany X-pert Med GmbH Jena Thüringen

Sponsors (1)

Lead Sponsor Collaborator
IDEA AG

Country where clinical trial is conducted

Germany, 

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