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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: intravenous diclofenac sodium (DIC075V); Drug: ketorolac; Drug: oral diclofenac (Cataflam); Drug: aspirin

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Javelin Pharmaceuticals
• Investigators: Study Director: Javelin Pharmaceuticals, Javelin Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: October 22, 2007
• First Submitted That Met QC Criteria: October 23, 2007
• First Posted (Estimate): October 24, 2007

Study Record Updates

• Last Update Posted (Estimate): July 16, 2008
• Last Update Submitted That Met QC Criteria: July 15, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: diclofenac, platelet aggregation, ketorolac, aspirin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin; Ketorolac; Diclofenac
• Other Study ID Numbers: DFC-007