NCT00442585

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

First QC Date

March 1, 2007

Last Update Submit

March 12, 2012

Conditions

Drug Interactions

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

  • prostacyclin metabolite

Interventions

S(+)-ibuprofenDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy caucasian volunteer
  • Must be able to swallow tablets

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 15811481BACKGROUND

Study Officials

  • Christian Joukhadar, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 1, 2007

First Posted

March 2, 2007

Study Start

September 1, 2006

Study Completion

October 1, 2007

Last Updated

March 13, 2012

Record last verified: 2012-03

Locations

AU(1)