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

• Sponsor: Javelin Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00548678
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 4
• Duration (Months): 1
• Patients Per Site Per Month: 29.5

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Oct 1, 2007
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Arms and Interventions

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

Outcome Measures

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. [6 hours]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Phase One	Miramar	Florida	United States	33025

Sponsors and Collaborators

• Javelin Pharmaceuticals

Investigators

• Study Director: Javelin Pharmaceuticals, Javelin Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00548678
• Other Study ID Numbers: DFC-007
• First Posted: Oct 24, 2007
• Last Update Posted: Jul 16, 2008
• Last Verified: Jul 1, 2008

• Keywords provided by , ,: diclofenac, platelet aggregation, ketorolac, aspirin
• Additional relevant MeSH terms: Aspirin; Diclofenac; Ketorolac

Study Results

No Results Posted as of Jul 16, 2008