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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

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

U.S. FDA Resources

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
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

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

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
Pharmacologic Actions
Anti-Inflammatory Agents

Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012