Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers - Full Text View

Sponsored by:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00548678

Purpose

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	Intervention	Phase
Healthy	Drug: intravenous diclofenac sodium (DIC075V) Drug: ketorolac Drug: oral diclofenac (Cataflam) Drug: aspirin	Phase I

Drug Information available for: Acetylsalicylic acid Diclofenac sodium Diclofenac potassium Diclofenac Ketorolac Ketorolac tromethamine Tromethamine

U.S. FDA Resources

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

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100. [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	October 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental intravenous diclofenac sodium	Drug: intravenous diclofenac sodium (DIC075V) intravenous diclofenac sodium
B: Active Comparator intravenous ketorolac	Drug: ketorolac intravenous ketorolac
C: Active Comparator oral diclofenac (Cataflam)	Drug: oral diclofenac (Cataflam) oral diclofenac (Cataflam)
D: Active Comparator oral aspirin	Drug: aspirin oral aspirin

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548678

Locations

United States, Florida
Comprehensive Phase One
Miramar, Florida, United States, 33025

Sponsors and Collaborators

Javelin Pharmaceuticals

Investigators

Study Director:

Javelin Pharmaceuticals

More Information

No publications provided

Responsible Party:	Javelin Pharmaceuticals ( Javelin Pharmaceuticals )
Study ID Numbers:	DFC-007
Study First Received:	October 22, 2007
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00548678 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Javelin Pharmaceuticals:

diclofenac, platelet aggregation, ketorolac, aspirin

Study placed in the following topic categories:

Anti-Inflammatory Agents
Cyclooxygenase Inhibitors
Ketorolac
Diclofenac
Fibrinolytic Agents
Cardiovascular Agents
Healthy
Fibrin Modulating Agents

Aspirin
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Ketorolac Tromethamine
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Ketorolac
Physiological Effects of Drugs
Diclofenac
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents

Aspirin
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Ketorolac Tromethamine
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009