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

NCT ID: NCT00548678

Last Updated: 2008-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-11-30

Brief Summary

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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

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

Conditions

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Healthy

Keywords

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diclofenac, platelet aggregation, ketorolac, aspirin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

intravenous diclofenac sodium

Group Type EXPERIMENTAL

intravenous diclofenac sodium (DIC075V)

Intervention Type DRUG

intravenous diclofenac sodium

B

intravenous ketorolac

Group Type ACTIVE_COMPARATOR

ketorolac

Intervention Type DRUG

intravenous ketorolac

C

oral diclofenac (Cataflam)

Group Type ACTIVE_COMPARATOR

oral diclofenac (Cataflam)

Intervention Type DRUG

oral diclofenac (Cataflam)

D

oral aspirin

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

oral aspirin

Interventions

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intravenous diclofenac sodium (DIC075V)

intravenous diclofenac sodium

Intervention Type DRUG

ketorolac

intravenous ketorolac

Intervention Type DRUG

oral diclofenac (Cataflam)

oral diclofenac (Cataflam)

Intervention Type DRUG

aspirin

oral aspirin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Javelin Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Javelin Pharmaceuticals

Principal Investigators

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Javelin Pharmaceuticals

Role: STUDY_DIRECTOR

Javelin Pharmaceuticals

Locations

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Comprehensive Phase One

Miramar, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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DFC-007

Identifier Type: -

Identifier Source: org_study_id