S(+)-Ibuprofen Effects on Asprin Treated Volunteers

This study has been completed.

First Received on March 1, 2007. No Changes Posted

Sponsor:	Gebro Pharma GmbH
Information provided by:	Gebro Pharma GmbH
ClinicalTrials.gov Identifier:	NCT00442585

Purpose

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

Condition	Intervention	Phase
Drug Interactions	Drug: S(+)-ibuprofen	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Ibuprofen

U.S. FDA Resources

Further study details as provided by Gebro Pharma GmbH:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	72
Study Start Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442585

Locations

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

Sponsors and Collaborators

Gebro Pharma GmbH

Investigators

Principal Investigator:

Christian Joukhadar, MD

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

More Information

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.

ClinicalTrials.gov Identifier:	NCT00442585 History of Changes
Other Study ID Numbers:	Gebro-I-24-13, EUDRACT 2006-002159-33
Study First Received:	March 1, 2007
Last Updated:	March 1, 2007
Health Authority:	Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:

Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012