Study Stopped
change in the business strategy of the sponsor
Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus
Assessment of the Effects of Zegerid Powder for Oral Suspension 40 mg on 24-Hour and Nocturnal Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease and Barrett's Esophagus
1 other identifier
interventional
27
1 country
1
Brief Summary
The purpose of this research study is to assess how safe, effective (how well it works), and tolerable (to put up with) the drug Zegerid is in reducing reflux episodes in patients who have both gastroesophageal reflux disease (GERD) and Barrett's esophagus. Zegerid has been approved by the US Food and Drug Administration (FDA) for the treatment of GERD. The investigators hope to learn the effectiveness of Zegerid for reducing the amount of acid reflux patients are experiencing in the esophagus (swallowing pipe).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 21, 2010
CompletedFirst Posted
Study publicly available on registry
May 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
June 6, 2017
CompletedJune 6, 2017
June 1, 2017
8 months
May 21, 2010
January 7, 2017
June 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Time Esophageal pH< 4
Reported as the the average percentage over 24 hours of total time, upright time, and supine time per day with pH \<4 (symptomatic acid state) as evaluated with the Bravo pH monitoring technique.
Days 1 and 2
Secondary Outcomes (1)
Reflux Disease Questionnaire Score on Day 1 After Therapy Completion
Day 1 after therapy period completion
Study Arms (1)
Received Zegerid (Ome-NaBic)
EXPERIMENTALAdministered Ome-NaBic 40 mg orally 1 h before breakfast and bedtime
Interventions
Eligibility Criteria
You may not qualify if:
- Zollinger-Ellison syndrome
- Endoscopic evidence or suspicion of a pathologic or infiltrative process in the stomach
- Positive for H. pylori.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- W. Ray Kim, MD, Chief of Gastroenterology and Hepatology
- Organization
- Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren B Gerson
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2010
First Posted
May 25, 2010
Study Start
November 1, 2009
Primary Completion
July 1, 2010
Study Completion
December 1, 2010
Last Updated
June 6, 2017
Results First Posted
June 6, 2017
Record last verified: 2017-06