S(+)-Ibuprofen Effects on Asprin Treated Volunteers

March 12, 2012 updated by: Gebro Pharma GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Department of Clinical Pharmacology, Medical University Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gebro Pharma GmbH

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

March 1, 2007

First Submitted That Met QC Criteria

March 1, 2007

First Posted (Estimate)

March 2, 2007

Study Record Updates

Last Update Posted (Estimate)

March 13, 2012

Last Update Submitted That Met QC Criteria

March 12, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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