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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01129778
First received: May 21, 2010
Last updated: May 24, 2010
Last verified: May 2010
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • Control of esophageal pH [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Control of GERD symptoms [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129778

Contacts
Contact: Lauren Gerson (650) 725-3376 lgerson@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Lauren Gerson    650-725-3376    lgerson@stanford.edu   
Contact: Necole Greer    (650) 725-3376      
Principal Investigator: Lauren B Gerson         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Lauren B Gerson Stanford University
  More Information

No publications provided

Responsible Party: Lauren B Gerson, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01129778     History of Changes
Other Study ID Numbers: SU-04302010-5803
Study First Received: May 21, 2010
Last Updated: May 24, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014