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S(+)-Ibuprofen Effects on Asprin Treated Volunteers

NCT ID: NCT00442585

Last Updated: 2012-03-13

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Drug Interactions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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S(+)-ibuprofen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gebro Pharma GmbH

INDUSTRY

Sponsor Role lead

Principal Investigators

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Christian Joukhadar, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Division of Clinical Pharmacokinetics, Medical Univerisity of Vienna

Locations

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Department of Clinical Pharmacology, Medical University Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 15811481 (View on PubMed)

Other Identifiers

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EUDRACT 2006-002159-33

Identifier Type: -

Identifier Source: secondary_id

Gebro-I-24-13

Identifier Type: -

Identifier Source: org_study_id

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