S(+)-Ibuprofen Effects on Asprin Treated Volunteers

This study has been completed.

Sponsor:

Information provided by:

Gebro Pharma GmbH

ClinicalTrials.gov Identifier:

NCT00442585

First received: March 1, 2007

Last updated: March 12, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 1, 2007

Last Updated Date

March 12, 2012

Start Date ^ICMJE

September 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Percentage of inhibition of TxB2 after 1, 3, 7 and 10 days

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00442585 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

S(+)-Ibuprofen Effects on Asprin Treated Volunteers

Official Title ^ICMJE

Double Blind, Randomised, Parallel Group, Placebo Controlled Clinical Trial of S(+)-Ibuprofen Effects on TxB2 Concentrations and Platelet Aggregation in Aspirin-treated Healthy Adult Volunteers

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Drug Interactions

Intervention ^ICMJE

Drug: S(+)-ibuprofen

Study Arm (s)

Not Provided

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT00442585

Other Study ID Numbers ^ICMJE

Gebro-I-24-13, EUDRACT 2006-002159-33

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Gebro Pharma GmbH

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christian Joukhadar, MD

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

Information Provided By

Gebro Pharma GmbH

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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