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Ann Arbor, Michigan 48105


Purpose:

This is a series of two prospective studies based on the Department of Veterans Affairs drug treatment guideline for the pharmacologic management of gastroesophageal reflux disease. Our hypothesis is that novel strategies for medical management of gastroesophageal reflux disease (GERD) can decrease resource utilization without adversely affecting patient quality of life. The strategies tested in this project included 1) step-down management, whereby patients rendered asymptomatic on proton pump inhibitors (PPIs) are treated with less expensive medication, and 2) intermittent therapy, defined as administration of medication only for recurrence of GERD symptoms. We chose to examine an intermittent strategy of PPI administration since in addition to the VA guideline requiring step-down therapy, over-the-counter PPIs administered by intermittent therapy became available for use by patients during the study period.


Study summary:

Background: This is a series of two prospective studies based on the Department of Veterans Affairs drug treatment guideline for the pharmacologic management of gastroesophageal reflux disease. Our hypothesis is that novel strategies for medical management of gastroesophageal reflux disease (GERD) can decrease resource utilization without adversely affecting patient quality of life. The strategies tested in this project included 1) step-down management, whereby patients rendered asymptomatic on proton pump inhibitors (PPIs) are treated with less expensive medication, and 2) intermittent therapy, defined as administration of medication only for recurrence of GERD symptoms. We chose to examine an intermittent strategy of PPI administration since in addition to the VA guideline requiring step-down therapy, over-the-counter PPIs administered by intermittent therapy became available for use by patients during the study period. Objectives: The objectives of this project are to determine the efficacy of step-down therapy and intermittent therapy in patients with GERD, and the impact of these strategies on direct healthcare costs and health-related quality of life (HRQOL). Additionally, we will examine patient factors predictive of non-response to these management strategies that may be alternatives to traditional continuous PPI administration. Methods: Two separate studies were conducted in our population of patients with GERD symptoms (heartburn or acid regurgitation) rendered asymptomatic on PPIs. Both studies randomized subjects to an intervention strategy (Step-down or Intermittent therapy) or to a control group in which PPIs were continued on a daily basis. Step-down therapy: Step-down subjects discontinued PPIs and were prescribed histamine2-receptor antagonists (H2RAs) for 2 weeks, and if still asymptomatic, H2RAs were discontinued. If symptoms recurred, H2RAs were reinitiated, and if still symptomatic, subjects were prescribed PPIs at the dose that initially alleviated their symptoms. Intermittent therapy: Intermittent therapy subjects discontinued daily use of PPIs and were prescribed short courses of PPI (daily for 8 weeks) for recurrence of GERD symptoms. The primary efficacy measure was the proportion of subjects remaining free of GERD symptoms while on their prescribed therapy (step-down group: no symptoms on H2RAs or no GERD medication; intermittent therapy group: no PPIs for �2 weeks after discontinuation, and < 3 symptom recurrences requiring PPIs; control groups: no GERD symptoms on PPI). Follow up was conducted for 6 months after randomization. In addition to the primary efficacy measure, we examined total resource utilization (pharmacy and non-pharmacy), HRQOL, and potential predictors of non-response to step-down or intermittent therapy (requirement of daily PPI to control symptoms). Logistic regression and random-effects models adjusted for covariates and clustering effects. Status: Enrollment and follow-up have been completed. Efficacy measures are reported above. Outcome measures including comparison of direct health care costs, health-related quality of life, and determinants of non-response to step-down or intermittent therapy are being examined.


Criteria:

Inclusion Criteria: 1. Patients with GERD symptoms treated with PPIs. For the purpose of this study, GERD symptoms include heartburn or acid regurgitation. Symptoms of dyspepsia (epigastric pain, nausea, bloating, early satiety) may be present, but may not be used as the sole criteria for inclusion into the study. 2. Asymptomatic (no heartburn or acid regurgitation) on PPI therapy. Exclusion Criteria: 1. Complications of gastroesophageal reflux disease including esophageal stricture, hemorrhage due to erosive esophagitis, Barrett�s esophagus or adenocarcinoma of the esophagus, or extra-esophageal manifestations of reflux disease (pulmonary or laryngeal disease due to acid reflux). 2. Concurrent diagnoses of other gastrointestinal diseases including gastric or duodenal ulcer, Zollinger-Ellison syndrome or other hypersecretory disorders, or gastric cancer. 3. Esophagitis secondary to non-acid peptic causes: infections (viral, bacterial, fungal), or medications causing esophageal erosions. 4. Inability to maintain follow-up, either due to excessive distance to the VA primary care facility or lack of telephone services. 5. Unwillingness to participate in the study.


NCT ID:

NCT00057174


Primary Contact:

Principal Investigator
John Inadomi, MD
VA Ann Arbor Healthcare System, Ann Arbor, MI


Backup Contact:

N/A


Location Contact:

Ann Arbor, Michigan 48105
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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