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Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers

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ClinicalTrials.gov Identifier: NCT00548678
Recruitment Status : Completed
First Posted : October 24, 2007
Last Update Posted : July 16, 2008
Sponsor:
Information provided by:
Javelin Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: intravenous diclofenac sodium (DIC075V) Drug: ketorolac Drug: oral diclofenac (Cataflam) Drug: aspirin Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
intravenous diclofenac sodium
Drug: intravenous diclofenac sodium (DIC075V)
intravenous diclofenac sodium
Active Comparator: B
intravenous ketorolac
Drug: ketorolac
intravenous ketorolac
Active Comparator: C
oral diclofenac (Cataflam)
Drug: oral diclofenac (Cataflam)
oral diclofenac (Cataflam)
Active Comparator: D
oral aspirin
Drug: aspirin
oral aspirin



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100. [ Time Frame: 6 hours ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548678


Locations
United States, Florida
Comprehensive Phase One
Miramar, Florida, United States, 33025
Sponsors and Collaborators
Javelin Pharmaceuticals
Investigators
Study Director: Javelin Pharmaceuticals Javelin Pharmaceuticals

Responsible Party: Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00548678     History of Changes
Other Study ID Numbers: DFC-007
First Posted: October 24, 2007    Key Record Dates
Last Update Posted: July 16, 2008
Last Verified: July 2008

Keywords provided by Javelin Pharmaceuticals:
diclofenac, platelet aggregation, ketorolac, aspirin

Additional relevant MeSH terms:
Aspirin
Diclofenac
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics