Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Barrett Esophagus; Gastroesophageal Reflux
Interventions:	Drug: Zegerid (proton pump inhibitor); Procedure: Bravo pH monitoring

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
5 participants withdrew after providing their informed consent and before beginning their participation in the study.

Reporting Groups

	Description
Received Zegerid (Ome-NaBic)	Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days

Participant Flow:   Overall Study

	Received Zegerid (Ome-NaBic)
STARTED	22
COMPLETED	15
NOT COMPLETED	7

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
21 participants who underwent pH testing were evaluable for Baseline Characteristics.

Reporting Groups

	Description
Received Zegerid (Ome-NaBic)	Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days

Baseline Measures

	Received Zegerid (Ome-NaBic)
Overall Participants Analyzed; [Units: Participants]	21
Age; [Units: Years]; Mean (Standard Deviation)	61 (10)
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	4 19.0%
Male	17 81.0%
Mean RDQ heartburn score [1]; [Units: Units on a scale]; Mean (Standard Deviation)	10 (6)
[1] The RDQ is a 12 item survey that asks the patient to rate the frequency and severity of GERD symptoms. Each item is scored from 0 to 5 where a score of 0 is equivalent to an asymptomatic state and 5 indicates the worst severity of GERD symptoms. The total RDQ is a sum of all 12 items, and can range from 0 to 60.

  Outcome Measures

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1. Primary:

Percentage of Time Esophageal pH< 4 [ Time Frame: Days 1 and 2 ]

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2. Secondary:

Reflux Disease Questionnaire Score on Day 1 After Therapy Completion [ Time Frame: Day 1 after therapy period completion ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The limitations included the small sample size, a cohort of patients with primarily short-segment BE, and the fact that the study relied on comparison of intraoesophageal pH levels on Ome-NaBic to other PPIs based on historical controls.

  More Information

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Certain Agreements:  

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  

Name/Title: W. Ray Kim, MD, Chief of Gastroenterology and Hepatology
Organization: Stanford University
phone: 650-725-6511
e-mail: wrkim@stanford.edu

Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT01129778 History of Changes
Other Study ID Numbers:	SU-04302010-5803
First Submitted:	May 21, 2010
First Posted:	May 25, 2010
Results First Submitted:	January 7, 2017
Results First Posted:	June 6, 2017
Last Update Posted:	June 6, 2017