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

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

• 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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetic
• Intervention / Treatment: Drug: Diractin; Drug: Diractin; Drug: Diractin; Drug: Diractin

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Jena, Germany
    • X-pert Med GmbH
  • Leipzig, Germany
    • ClinPharm Interantional GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

• 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
  • 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

• 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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2; 400 mg Ketoprofen from Diractin to 4 joints	Drug: Diractin; 100 mg Ketoprofen to 2 joints; Drug: Diractin; 400 mg ketoprofen to 4 joints; Drug: Diractin; 100 and 400 mg Ketoprofen used concomittant with heat; Drug: Diractin; 100 and 400 mg Ketoprofen concomittant with moderate exercise
Experimental: 3; 100 and 400 mg Ketoprofen used concomittant with heat	Drug: Diractin; 100 mg Ketoprofen to 2 joints; Drug: Diractin; 400 mg ketoprofen to 4 joints; Drug: Diractin; 100 and 400 mg Ketoprofen used concomittant with heat; Drug: Diractin; 100 and 400 mg Ketoprofen concomittant with moderate exercise
Experimental: 4; 100 and 400 mg Ketoprofen concomittant with moderate exercise	Drug: Diractin; 100 mg Ketoprofen to 2 joints; Drug: Diractin; 400 mg ketoprofen to 4 joints; Drug: Diractin; 100 and 400 mg Ketoprofen used concomittant with heat; Drug: Diractin; 100 and 400 mg Ketoprofen concomittant with moderate exercise
Experimental: 1; 100 mg ketoprofen to 2 joints	Drug: Diractin; 100 mg Ketoprofen to 2 joints; Drug: Diractin; 400 mg ketoprofen to 4 joints; Drug: Diractin; 100 and 400 mg Ketoprofen used concomittant with heat; Drug: Diractin; 100 and 400 mg Ketoprofen concomittant with moderate exercise

Collaborators and Investigators

• Sponsor: IDEA AG
• Investigators: Principal Investigator: Egbert Seidel, MD, PhD, X-pert Med GmbH

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: September 2, 2008
• First Submitted That Met QC Criteria: September 2, 2008
• First Posted (Estimate): September 3, 2008

Study Record Updates

• Last Update Posted (Estimate): March 20, 2009
• Last Update Submitted That Met QC Criteria: March 19, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: exercise; heat
• Other Study ID Numbers: CL-033-I-04