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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01370525 |
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Date of registration:
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01/06/2011 |
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Primary sponsor: |
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Public title:
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Efficacy of Esomeprazole in Patients With Frequent Heartburn
NEXT1 |
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Scientific title:
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A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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486 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01370525 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Tore Lind, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males and non-pregnant ,non-lactating females 18 years or older
- Experience heartburn at least 2 days a week
- Having heartburn that has responded to heartburn medication
- Must discontinue any current heartburn medications
Exclusion Criteria:
- Having a history of erosive esophagitis verified by endoscopy
- Having a history of GERD which was diagnosed by a physician
- Be unwilling to take study medication and the antacid provided as a rescue medication
- Males and females less than 18 years old or females who are pregnant or are lactating
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Heartburn
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Intervention(s)
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Drug: Esomeprazole
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Primary Outcome(s)
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Determine efficacy during free 24-hour days during 14 days of treatment
[Time Frame: During the 2 weeks of treatment]
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Secondary Outcome(s)
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Determine efficacy over days 1-4
[Time Frame: During first 4 days of the 2 week treatment]
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Determine proportion of subjects during the final week of treatment
[Time Frame: During last 7 days of the 2 week treatment]
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Secondary ID(s)
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D961RC00001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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