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AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers
This study has been completed.
Sponsor:
Allergan
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00325715
First received: May 11, 2006
Last updated: June 1, 2011
Last verified: June 2011
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | May 11, 2006 | ||
| Last Updated Date | June 1, 2011 | ||
| Start Date ICMJE | April 2006 | ||
| 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 Blind 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 | ||
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* 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 | ||
| Enrollment ICMJE | 150 | ||
| Completion Date | August 2006 | ||
| 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 | ||
| Plan to Share Data | Not Provided | ||
| IPD Description | 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 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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