S(+)-Ibuprofen Effects on Asprin Treated Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00442585
Recruitment Status : Completed
First Posted : March 2, 2007
Last Update Posted : March 13, 2012
Information provided by:
Gebro Pharma GmbH

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

Condition or disease Intervention/treatment Phase
Drug Interactions Drug: S(+)-ibuprofen Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Percentage of inhibition of TxB2 after 1, 3, 7 and 10 days

Secondary Outcome Measures :
  1. percentage of subjects with >90% inhibition of TxB2, CEPI-CT and CADP-CT measured by PAF100,
  2. prostacyclin metabolite

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00442585

Department of Clinical Pharmacology, Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Gebro Pharma GmbH
Principal Investigator: Christian Joukhadar, MD Department of Clinical Pharmacology, Division of Clinical Pharmacokinetics, Medical Univerisity of Vienna

Publications: Identifier: NCT00442585     History of Changes
Other Study ID Numbers: Gebro-I-24-13
EUDRACT 2006-002159-33
First Posted: March 2, 2007    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action