Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus
|ClinicalTrials.gov Identifier: NCT01129778|
Recruitment Status : Terminated (change in the business strategy of the sponsor)
First Posted : May 25, 2010
Results First Posted : June 6, 2017
Last Update Posted : June 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Barrett Esophagus Gastroesophageal Reflux||Drug: Zegerid (proton pump inhibitor) Procedure: Bravo pH monitoring||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||December 2010|
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129778
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Lauren B Gerson||Stanford University|