Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus
| Status: | Completed |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | November 2009 |
| End Date: | December 2010 |
| Contact: | Lauren Gerson |
| Email: | lgerson@stanford.edu |
| Phone: | (650) 725-3376 |
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
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).
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).
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.
- 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.
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.
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