Assess Platelet Function and Safety After Administration of Injectable Diclofenac Compared to Ketorolac and Aspirin in Adult Male Volunteers
Information source: Javelin Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: intravenous diclofenac sodium (DIC075V) (Drug); ketorolac (Drug); cataflam (Drug); aspirin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Javelin Pharmaceuticals Official(s) and/or principal investigator(s):
Javelin Pharmaceuticals, Study Director, Affiliation: Javelin Pharmaceuticals
Summary
This study will assess platelet function and safety in healthy male volunteers following
doses of intravenous diclofenac compared to cataflam, intravenous ketorolac and aspirin.
Clinical Details
Official title: Open-Label, Randomized, Single-Dose, Four-Treatment Crossover Study to Evaluate Platelet Function in Healthy Adult Male Volunteers Following Administration of IV Diclofenac Sodium, Oral Diclofenac Potasssium, IV Ketorolac Tromethamine 30 mg and Acetylsalicylic Acid
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety Study
Primary outcome: Area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100.
Secondary outcome: The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100.
Detailed description:
The primary objective is to evaluate platelet function following all 4 doses of intravenous
diclofenac, cataflam, intravenous ketorolac and aspirin.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Comprehensive Phase One, Miramar, Florida 33025, United States
Additional Information
Starting date: October 2007
Ending date: November 2007
Last updated: February 8, 2008
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