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

This study has been terminated.
(change in the business strategy of the sponsor)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01129778
First Posted: May 25, 2010
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanford University
  Purpose
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).

Condition Intervention
Barrett Esophagus Gastroesophageal Reflux Drug: Zegerid (proton pump inhibitor) Procedure: Bravo pH monitoring

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Percentage of Time Esophageal pH< 4 [ Time Frame: Days 1 and 2 ]
    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.


Secondary Outcome Measures:
  • Reflux Disease Questionnaire Score on Day 1 After Therapy Completion [ Time Frame: Day 1 after therapy period completion ]
    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.


Enrollment: 27
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Received Zegerid (Ome-NaBic)
Administered Ome-NaBic 40 mg orally 1 h before breakfast and bedtime
Drug: Zegerid (proton pump inhibitor)
Other Name: Omeprazole-sodium bicarbonate (Ome-NaBic)
Procedure: Bravo pH monitoring

Detailed Description:

The following procedures will be performed at the Screening Visit:

  • Obtain informed consent.
  • Obtain information about your age and gender.
  • Evaluate whether you qualify for the study.
  • Document prior negative testing for H. pylori infection (a bacterial infection in the stomach that can cause ulcers) including the date of testing.
  • Make sure that you have not used any investigational medications or participated in a clinical trial in the 30 days prior to the Screening Visit.
  • Obtain medical history.
  • Record medication history (including concomitant medications).
  • Obtain vital signs.
  • Conduct a physical examination.
  • If a Bravo pH study has not been done within 8 weeks, instruct the patient to discontinue their medication for GERD during the 7-10 day washout period.
  • Instruct the patient to discontinue the use of all prohibited medications during the applicable time intervals and not to start any new concomitant medications during the trial.
  • Distribute Gelusil tablets to be used as "rescue medication"; instruct the patient that no more than 6 Gelusil tablets per day or 21 tablets over any 7-day interval will be allowed.
  • Schedule the patient to return for the Qualification Visit, or for pH monitoring and the Qualification Visit. Only patients with abnormal pH monitoring will be able to enter the treatment period.

Procedures that will occur during the Treatment Period:

  • You will receive Zegerid 1 hour before breakfast and at bedtime for at least 14 days and no longer than 28 days
  • At the end of the Zegerid treatment period, you will undergo 48-hour Bravo pH monitoring on Zegerid therapy for two days. You will complete a symptom survey and quality of life survey after the completion of the pH study.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria include adult men and women (aged <=18 years) with previously established, biopsy-proven diagnosis of BE (any length intestinal metaplasia without dysplasia or adenocarcinoma)

Exclusion Criteria:

  • Exclusion criteria include a history of esophageal, gastric, or duodenal surgery (including antireflux surgery or endoscopic antireflux procedures), except for simple ulcer closure
  • Zollinger-Ellison syndrome
  • Endoscopic evidence or suspicion of a pathologic or infiltrative process in the stomach
  • Positive for H. pylori.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129778


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Lauren B Gerson Stanford University
  More Information

Additional Information:
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
Last Verified: June 2017

Additional relevant MeSH terms:
Gastroesophageal Reflux
Barrett Esophagus
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Digestive System Abnormalities
Proton Pump Inhibitors
Omeprazole, sodium bicarbonate drug combination
Omeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents