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

• ClinicalTrials.gov Identifier: NCT00548678
• Recruitment Status: Completed
• First Posted: October 24, 2007
• Last Update Posted: July 16, 2008
• Sponsor: Javelin Pharmaceuticals
• Information provided by: Javelin Pharmaceuticals

Tracking Information

• First Submitted Date: October 22, 2007
• First Posted Date: October 24, 2007
• Last Update Posted Date: July 16, 2008
• Study Start Date: October 2007
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 8, 2008): 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 ]
• Original Primary Outcome Measures (submitted: October 23, 2007): 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.
• Current Secondary Outcome Measures (submitted: February 8, 2008): The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100. [ Time Frame: 6 hours ]
• Original Secondary Outcome Measures (submitted: October 23, 2007): The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers
• 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
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy

Intervention

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

Study Arms

• Experimental: A
  intravenous diclofenac sodium
  Intervention: Drug: intravenous diclofenac sodium (DIC075V)
• Active Comparator: B
  intravenous ketorolac
  Intervention: Drug: ketorolac
• Active Comparator: C
  oral diclofenac (Cataflam)
  Intervention: Drug: oral diclofenac (Cataflam)
• Active Comparator: D
  oral aspirin
  Intervention: Drug: aspirin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 23, 2007): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2007
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00548678
• Other Study ID Numbers: DFC-007
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Javelin Pharmaceuticals
• Original Responsible Party: Not Provided
• Current Study Sponsor: Javelin Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Javelin Pharmaceuticals; Javelin Pharmaceuticals

• PRS Account: Javelin Pharmaceuticals
• Verification Date: July 2008