A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia (AspECT)
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ClinicalTrials.gov Identifier: NCT00357682 |
Recruitment Status : Unknown
Verified May 2016 by University of Oxford.
Recruitment status was: Active, not recruiting
First Posted : July 27, 2006
Last Update Posted : May 18, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | July 26, 2006 | |||
First Posted Date ICMJE | July 27, 2006 | |||
Last Update Posted Date | May 18, 2016 | |||
Study Start Date ICMJE | March 2005 | |||
Estimated Primary Completion Date | May 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Conversion of Barrett's esophagus to adenocarcinoma of the esophagus or high-grade dysplasia [ Time Frame: assessed every 2 years ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
All causes of mortality [ Time Frame: assessed annually ] | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia | |||
Official Title ICMJE | A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia | |||
Brief Summary | RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of esomeprazole and aspirin may prevent esophageal cancer in patients with Barrett's metaplasia. It is not yet known whether esomeprazole is more effective with or without aspirin in preventing esophageal cancer in patients with Barrett's metaplasia. PURPOSE: This randomized phase III trial is studying esomeprazole with or without aspirin to compare how well they work in preventing esophageal cancer in patients with Barrett's metaplasia. |
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Detailed Description | PRIMARY OBJECTIVES
SECONDARY OBJECTIVES
Cancer Research UK approved the study in 2003 for a 10 year period to run from 1st January 2005 to 31st December 2014. Funding is renewable annually and is dependent on a satisfactory review by an independent committee. An application for a funding extension will be made to CRUK 18 months before the end of the current grant. A total of 2513 patients have been accrued for this study. They remain on trial medication and follow up. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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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 | Unknown status | |||
Actual Enrollment ICMJE |
2513 | |||
Original Enrollment ICMJE | Not Provided | |||
Estimated Study Completion Date ICMJE | May 2017 | |||
Estimated Primary Completion Date | May 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | INCLUSION CRITERIA
EXCLUSION CRITERIA
If a patient was suitable for inclusion but later becomes unsuitable this should be discussed with the Trial Office before they are withdrawn. Only in exceptional circumstances should patients not be followed up i.e. withdrawal of consent or current life threatening disease with poor outcome and therefore unable to tolerate endoscopy. In these circumstances patients should be followed up in outpatient clinics. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United Kingdom | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00357682 | |||
Other Study ID Numbers ICMJE | CDR0000491649 OCTO-003 ( Other Identifier: Oncology Clinical Trials Office ) 2004-003836-77 ( EudraCT Number ) ISRCTN85156844 ( Registry Identifier: ISRCTN ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | University of Oxford | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | University of Oxford | |||
Original Study Sponsor ICMJE | Oxford University Hospitals NHS Trust | |||
Collaborators ICMJE | AstraZeneca | |||
Investigators ICMJE |
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PRS Account | University of Oxford | |||
Verification Date | May 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |