NCT00548678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2007

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

July 16, 2008

Status Verified

July 1, 2008

Enrollment Period

1 month

First QC Date

October 22, 2007

Last Update Submit

July 15, 2008

Conditions

Healthy

Keywords

diclofenac, platelet aggregation, ketorolac, aspirin

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

    6 hours

Study Arms (4)

A

EXPERIMENTAL

intravenous diclofenac sodium

Drug: intravenous diclofenac sodium (DIC075V)

B

ACTIVE COMPARATOR

intravenous ketorolac

Drug: ketorolac

C

ACTIVE COMPARATOR

oral diclofenac (Cataflam)

Drug: oral diclofenac (Cataflam)

D

ACTIVE COMPARATOR

oral aspirin

Drug: aspirin

Interventions

intravenous diclofenac sodium (DIC075V)DRUG

intravenous diclofenac sodium

A
ketorolacDRUG

intravenous ketorolac

B
oral diclofenac (Cataflam)DRUG

oral diclofenac (Cataflam)

C
aspirinDRUG

oral aspirin

D

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Bleeding abnormalities or cardiovascular events.
  • Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Phase One

Miramar, Florida, 33025, United States

Location

MeSH Terms

Interventions

KetorolacDiclofenacAspirin

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Javelin Pharmaceuticals

    Javelin Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 22, 2007

First Posted

October 24, 2007

Study Start

October 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

July 16, 2008

Record last verified: 2008-07

Locations

US(1)