AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT00325715 |
Recruitment Status
:
Completed
First Posted
: May 15, 2006
Last Update Posted
: June 2, 2011
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Sponsor:
Allergan
Information provided by:
Allergan
Tracking Information | |||
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First Submitted Date ICMJE | May 11, 2006 | ||
First Posted Date ICMJE | May 15, 2006 | ||
Last Update Posted Date | June 2, 2011 | ||
Study Start Date ICMJE | April 2006 | ||
Actual Primary Completion Date | August 2006 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Stomach or upper intestinal erosions | ||
Original Primary Outcome Measures ICMJE |
Stomach and upper intestinal erosions | ||
Change History | Complete list of historical versions of study NCT00325715 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers | ||
Official Title ICMJE | Not Provided | ||
Brief Summary | AGN 201904, a proton pump inhibitor, versus esomeprazole in the prevention of stomach or upper intestinal damage following administration of high-dose aspirin in healthy volunteers | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 1 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Primary Purpose: Prevention |
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Condition ICMJE | Peptic Ulcer | ||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
150 | ||
Original Enrollment ICMJE | Same as current | ||
Actual Study Completion Date | August 2006 | ||
Actual Primary Completion Date | August 2006 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | ||
Accepts Healthy Volunteers | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00325715 | ||
Other Study ID Numbers ICMJE | 201904-006 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Therapeutic Area Head, Allergan, Inc | ||
Study Sponsor ICMJE | Allergan | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Allergan | ||
Verification Date | June 2011 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |