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

Phase 2

Completed

• Conditions: Muscle Soreness
• Interventions: Drug: Diractin

• Registration Number: NCT00745771
• Lead Sponsor: IDEA AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-02
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Study Completion: 2008-11
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-19
• Last Update Posted: 2009-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Diractin	200 mg Ketoprofen
2	Diractin	100 mg Ketoprofen

Trial Locations

Locations (1)

X-pert Med GmbH; 🇩🇪 Jena, Thüringen, Germany