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 - Pharmacokinetic of Diractin and effect on muscle soreness

• Conditions: The study population is a healthy population who are voluntarily participating in this clinical trial. This study will compare the PK profile after e.c. and oral application of the same dosage of ketoprofen and in a dosage range as intended for clinical use in OA. It will also indicate whether application on muscle will result in a different PK profile as compared to application on a joint.The intended use for Diractin® will be osteoarthritis of the knee; MedDRA version: 9.1Level: LLTClassification code 10028332Term: Muscle soreness

• Registration Number: EUCTR2007-002581-35-DE
• Lead Sponsor: IDEA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• 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
•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)
•Muscle soreness with a pain score of at least 3 on a 10 point categorical pain scale at 12-16h after exercise

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
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
• Blood donation one month before screening and during the study
•Asthma bronchiale
•Medication during the study observation period (Screening to final Visit) containing
oDigoxin
oPhenytoin
oLithium
oGlucocorticoids
oNSAID´s
oProbenecid
oSulfinpyrazon
•Diuretics during the study observation period (Screening to final Visit)
•ACE inhibitors during the study observation period (Screening to final Visit)
•Anticoagulants during the study observation period (Screening to final Visit)
•Methotrexat during the study observation period (Screening to final Visit)
•Antacids during the study observation period (Screening to final Visit)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified