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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014