S(+)-Ibuprofen Effects on Asprin Treated Volunteers

• Sponsor: Gebro Pharma GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00442585
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Sep 1, 2006
• Actual Study Completion Date: Oct 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

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
• Other Study ID Numbers: Gebro-I-24-13; EUDRACT 2006-002159-33
• First Posted: Mar 2, 2007
• Last Update Posted: Mar 13, 2012
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Ibuprofen

Study Results

No Results Posted as of Mar 13, 2012