Comparison of Acid Reflux at Two Levels in the Esophagus Using the BRAVO Capsule

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00579410
First received: December 21, 2007
Last updated: March 21, 2011
Last verified: March 2011
  Purpose

The purpose of this research is to study the level of acid exposure above the gastroesophageal junction and the distal esophagus in patients with reflux symptoms using a capsule type acid measurement system. Patients with reflux symptoms are likely to have more acid reflux just above the junction of the stomach and the esophagus that may help to improve the diagnosis of gastroesophageal reflux disease (GERD). This may help better treat the reflux symptoms.


Condition
Esophagitis
Inflammation
Gastritis
Abdominal Pain
Heartburn

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Esophageal and Gastric Acid Levels in Patients Presenting With Upper Gastrointestinal Symptoms Using a Novel PH System

Resource links provided by NLM:


Further study details as provided by Kansas City Veteran Affairs Medical Center:

Primary Outcome Measures:
  • This pilot project will attempt to study the level of acid exposure in the distal esophagus and proximal stomach of patients and correlate it with their symptoms. [ Time Frame: 24 hour period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To note patient satisfaction and comfort during the pH monitoring process. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: May 2004
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Patients with Barrett's Esophagus
B
Patients with reflux symptoms but no Barrett's Esophagus
C
Patients without reflux symptoms and a normal endoscopy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The subjects in this study were selected from veterans ages 18 and above presenting for an upper endoscopy

Criteria

Inclusion Criteria:

  1. Patients referred for upper endoscopy for any reason including those with acid reflux, dyspepsia, weight loss, Barrett's esophagus,suspected Helicobacter pylori infection.
  2. Patients able to provide written informed consent.

Exclusion Criteria:

  1. Lack of severe comorbid conditions precluding an upper endoscopy.
  2. Patients with history of esophageal or gastric cancer.
  3. Patients status post esophageal or gastric resection.
  4. Patients with esophageal varices.
  5. Patients with severe esophageal strictures.
  6. Patients with acute upper gastrointestinal bleeding.
  7. Inability to provide informed written consent.
  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: NCT00579410

Locations
United States, Missouri
Department of Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Principal Investigator: Prateek Sharma, MD Department of Veterans Affairs Medical Center of Kansas City
  More Information

Publications:
23. Carlsson R, Bolling E, Jerndal , et al. Factors predicting response to omeprazole treatment in patients with functional dyspepsia. Gastroenterology 1996;110:A76.

Responsible Party: Prateek Sharma, MD, Department of Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00579410     History of Changes
Other Study ID Numbers: PS0019
Study First Received: December 21, 2007
Last Updated: March 21, 2011
Health Authority: Human Studies Committee: Department of Veterans Affairs Medical Center, Kansas City, MO USA
United States: Federal Government

Keywords provided by Kansas City Veteran Affairs Medical Center:
gastric acid
esophageal reflux
peptic ulcer
heartburn

Additional relevant MeSH terms:
Inflammation
Esophagitis
Abdominal Pain
Heartburn
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on September 29, 2014