Multi-Centre, Open-Label, Two Segment, Study Comparing Plasma Pharmacokinetics of Ketoprofen in Diractin® Alone to Diractin® Applied Concomitant With Heat or Moderate Exercise

NCT ID: NCT00745264

Last Updated: 2009-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-05-31

Brief Summary

• Comparison of the plasma PK after single use of 100 mg ketoprofen from Diractin®. 50 mg applied on 2 major joints to
• 400 mg ketoprofen from Diractin® (100 mg applied to 4 joints - overexposure)
• 100 mg and 400 mg ketoprofen from Diractin® used concomitant with heat application
• 100 mg and 400 mg ketoprofen from Diractin® used concomitant with moderate exercise

Conditions

Pharmacokinetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

2

400 mg Ketoprofen from Diractin to 4 joints

Group Type: EXPERIMENTAL

Diractin

Intervention Type: DRUG

400 mg ketoprofen to 4 joints

3

100 and 400 mg Ketoprofen used concomittant with heat

Group Type: EXPERIMENTAL

Diractin

Intervention Type: DRUG

100 and 400 mg Ketoprofen used concomittant with heat

4

100 and 400 mg Ketoprofen concomittant with moderate exercise

Group Type: EXPERIMENTAL

Diractin

Intervention Type: DRUG

100 and 400 mg Ketoprofen concomittant with moderate exercise

1

100 mg ketoprofen to 2 joints

Group Type: EXPERIMENTAL

Diractin

Intervention Type: DRUG

100 mg Ketoprofen to 2 joints

Interventions

Diractin

100 mg Ketoprofen to 2 joints

Intervention Type: DRUG

Diractin

400 mg ketoprofen to 4 joints

Intervention Type: DRUG

Diractin

100 and 400 mg Ketoprofen used concomittant with heat

Intervention Type: DRUG

Diractin

100 and 400 mg Ketoprofen concomittant with moderate exercise

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All of the following criteria have to be met to include a subject in the study:

• 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)

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
• Not willing to refrain from exposing target areas after treatment to excessive ultraviolet light (solar radiation or solarium)
• Pregnancy or lactation

• 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
• 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
• Blood donation one (1) month before screening and during study
• Hepatitis B and C
• Asthma bronchiale

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

Sponsors

IDEA AG

INDUSTRY

Sponsor Role: lead

Principal Investigators

Egbert Seidel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

X-pert Med GmbH

Locations

X-pert Med GmbH

Jena, , Germany

ClinPharm Interantional GmbH

Leipzig, , Germany

Countries

Germany

Other Identifiers

CL-033-I-04

Identifier Type: -

Identifier Source: org_study_id