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

NCT ID: NCT00745771

Last Updated: 2009-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-11-30

Brief 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.

Conditions

Muscle Soreness

Study Design

• Primary Study Purpose: TREATMENT

Study Groups

1

200 mg Ketoprofen

Group Type: ACTIVE_COMPARATOR

Diractin

Intervention Type: DRUG

2

100 mg Ketoprofen

Group Type: ACTIVE_COMPARATOR

Diractin

Intervention Type: DRUG

Interventions

Diractin

Intervention Type: DRUG

Diractin

Intervention Type: DRUG

Eligibility 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IDEA AG

INDUSTRY

Sponsor Role: lead

Responsible Party

IDEA AG

Principal Investigators

Egbert Seidel, MD

Role: PRINCIPAL_INVESTIGATOR

X-pert Med Jena

Locations

X-pert Med GmbH

Jena, Thuringia, Germany

Countries

Germany

Other Identifiers

CL-033-II-02

Identifier Type: -

Identifier Source: org_study_id