S(+)-Ibuprofen Effects on Asprin Treated Volunteers | NCT00442585

Studies
S(+)-Ibuprofen Effects on Asprin Treated Volunteers

NCT00442585

Sponsor

Gebro Pharma GmbH

Status

Completed

Last Update Posted

Mar 13, 2012Estimated

Enrollment

Phase

Phase 1

Conditions

Drug Interactions

Interventions

S(+)-ibuprofen

Countries

Austria

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

ID	Type	Description	Link
EUDRACT 2006-002159-33

Status Module

Record Verification Date

Mar 2012

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

Sep 2006

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Mar 1, 2007

First Submission Date that Met QC Criteria

Mar 1, 2007

First Posted Date

Mar 2, 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

Mar 12, 2012

Last Update Posted Date

Mar 13, 2012Estimated

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

The purpose of this clinical trial is to determine whether S(+)-ibuprofen affect the platelet inhibition under steady state acetylsalicylic acid conditions.

Detailed Description

Not provided

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

Name	Type	Description	Arm Group Labels	Other Names
S(+)-ibuprofen	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of inhibition of TxB2 after 1, 3, 7 and 10 days

Secondary Outcomes

Measure	Description	Time Frame
percentage of subjects with >90% inhibition of TxB2, CEPI-CT and CADP-CT measured by PAF100,
prostacyclin metabolite

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy caucasian volunteer
Must be able to swallow tablets

Exclusion Criteria:

Underlying diseases
Ulcus pepticum in history
Abuse of alcoholic beverages (40g/d)
Hypersensitivity to investigational medicinal products

Accepts Healthy Volunteers

Yes

Sex

All

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
Christian Joukhadar, MD	Department of Clinical Pharmacology, Division of Clinical Pharmacokinetics, Medical Univerisity of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Pharmacology, Medical University Vienna		Vienna	State of Vienna	1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15811481	Background	Cryer B, Berlin RG, Cooper SA, Hsu C, Wason S. Double-blind, randomized, parallel, placebo-controlled study of ibuprofen effects on thromboxane B2 concentrations in aspirin-treated healthy adult volunteers. Clin Ther. 2005 Feb;27(2):185-91. doi: 10.1016/j.clinthera.2005.01.011.