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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: intravenous diclofenac sodium (DIC075V); Drug: aspirin; Drug: oral diclofenac (Cataflam); Drug: ketorolac

• Registration Number: NCT00548678
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-23
• Study First Posted: 2007-10-24
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-15
• Last Update Posted: 2008-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	intravenous diclofenac sodium (DIC075V)	intravenous diclofenac sodium
D	aspirin	oral aspirin
C	oral diclofenac (Cataflam)	oral diclofenac (Cataflam)
B	ketorolac	intravenous ketorolac

Primary Outcome Measures

Name	Time	Method
Area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100.	6 hours

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100.	6 hours

Trial Locations

Locations (1)

Comprehensive Phase One; 🇺🇸 Miramar, Florida, United States