Platelet Function and Safety After IV and Oral Diclofenac... | NCT00548678

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

NCT00548678

Sponsor

Javelin Pharmaceuticals

Status

Completed

Last Update Posted

Jul 16, 2008Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

intravenous diclofenac sodium (DIC075V)
ketorolac
oral diclofenac (Cataflam)
aspirin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Nov 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Oct 22, 2007

First Submission Date that Met QC Criteria

Oct 23, 2007

First Posted Date

Oct 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2008

Last Update Posted Date

Jul 16, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
intravenous diclofenac sodium (DIC075V)	Drug	intravenous diclofenac sodium	A

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Javelin Pharmaceuticals	Javelin Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Comprehensive Phase One		Miramar	Florida	33025	United States

Intervention Browse Module

MeSH Terms

ID	Term
D020910	Ketorolac
D004008	Diclofenac
D001241	Aspirin

Ancestor Terms

ID	Term
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided