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NCT00442585 Clinical Trial

S(+)-Ibuprofen Effects on Asprin Treated Volunteers

Drug Interactions Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00442585
Other study ID # Gebro-I-24-13
Secondary ID EUDRACT 2006-002
Status Completed
Phase Phase 1
First received March 1, 2007
Last updated March 12, 2012
Start date September 2006
Est. completion date October 2007

Study information
Verified date March 2012
Source Gebro Pharma GmbH
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• S(+)-ibuprofen

Locations
Country Name City State
Austria Department of Clinical Pharmacology, Medical University Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Gebro Pharma GmbH

Country where clinical trial is conducted

Austria, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of inhibition of TxB2 after 1, 3, 7 and 10 days
Secondary percentage of subjects with >90% inhibition of TxB2, CEPI-CT and CADP-CT measured by PAF100,
Secondary prostacyclin metabolite
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