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

Tracking Information

First Received Date ^ICMJE

October 22, 2007

Last Updated Date

July 15, 2008

Start Date ^ICMJE

October 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

The primary platelet function endpoint is area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100.

Change History

Complete list of historical versions of study NCT00548678 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Experimental: intravenous diclofenac sodium
Active Comparator: intravenous ketorolac
Active Comparator: oral diclofenac (Cataflam)
Active Comparator: oral aspirin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00548678

Responsible Party

Javelin Pharmaceuticals, Javelin Pharmaceuticals

Study ID Numbers ^ICMJE

DFC-007

Study Sponsor ^ICMJE

Javelin Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Javelin Pharmaceuticals

Information Provided By

Javelin Pharmaceuticals

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP