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
  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 1

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:


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
Study Completion Date: October 2007
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 12, 2012
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 August 28, 2014