Official Title: “Open-Label, Randomized, Single-Dose, Four-Treatment Crossover Study to Evaluate Platelet Function in Healthy Adult Males After Administration of IV Diclofenac Sodium, Oral Diclofenac Potasssium, IV Ketorolac Tromethamine, and Acetylsalicylic Acid”

This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety Study

Study Primary Completion Date: November 2007

The primary objective is to evaluate platelet function following intravenous diclofenac, oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.

Intervention(s) in this Clinical Trial

• Drug: intravenous diclofenac sodium (DIC075V)
  • intravenous diclofenac sodium
• Drug: ketorolac
  • intravenous ketorolac
• Drug: oral diclofenac (Cataflam)
  • oral diclofenac (Cataflam)
• Drug: aspirin
  • oral aspirin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • intravenous diclofenac sodium
• Active Comparator: B
  • intravenous ketorolac
• Active Comparator: C
  • oral diclofenac (Cataflam)
• Active Comparator: D
  • oral aspirin

Primary Measures

• Area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100.
  • Time Frame: 6 hours
    Safety Issue?: No

Secondary Measures

• The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100.
  • Time Frame: 6 hours
    Safety Issue?: No

Inclusion Criteria:

• Healthy male subjects.
• Willing and able to stay at the clinical site for approximately 8 nights over 9 days and to return to the clinic approximately 7 days after discharge.

Exclusion Criteria:

• Bleeding abnormalities or cardiovascular events.
• Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Javelin Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Javelin Pharmaceuticals Study Director Javelin Pharmaceuticals  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00548678

Study ID Number: DFC-007

ClinicalTrials.gov Identifier: NCT00548678

Health Authority: United States: Food and Drug Administration