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

This study has been completed.
Sponsor:
Information provided by:
IDEA AG
ClinicalTrials.gov Identifier:
NCT00745264
First received: September 2, 2008
Last updated: March 19, 2009
Last verified: March 2009
  Purpose
  • 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

Condition Intervention Phase
Pharmacokinetic
Drug: Diractin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by IDEA AG:

Enrollment: 80
Study Start Date: October 2007
Study Completion Date: May 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
400 mg Ketoprofen from Diractin to 4 joints
Drug: Diractin
400 mg ketoprofen to 4 joints
Experimental: 3
100 and 400 mg Ketoprofen used concomittant with heat
Drug: Diractin
100 and 400 mg Ketoprofen used concomittant with heat
Experimental: 4
100 and 400 mg Ketoprofen concomittant with moderate exercise
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745264

Locations
Germany
X-pert Med GmbH
Jena, Germany
ClinPharm Interantional GmbH
Leipzig, Germany
Sponsors and Collaborators
IDEA AG
Investigators
Principal Investigator: Egbert Seidel, MD, PhD X-pert Med GmbH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00745264     History of Changes
Other Study ID Numbers: CL-033-I-04
Study First Received: September 2, 2008
Last Updated: March 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by IDEA AG:
heat
exercise

Additional relevant MeSH terms:
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014