NCT00061724

Brief Summary

The purpose of this project is to lay the groundwork for a proposed clinical trial to compare the effectiveness of two approaches to gastroesophageal reflux disease: treatment with medications and treatment with anti-reflux surgery. This project includes a non-interventional pilot study to test ways of measuring outcomes of treatment, and to gauge potential participants' willingness to enroll in the proposed clinical trial.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2003

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

First QC Date

June 3, 2003

Last Update Submit

January 12, 2010

Conditions

Keywords

EsophagealReflux

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-80
  • diagnosis of gastroesophageal reflux disease
  • have taken proton pump inhibitor medications

You may not qualify if:

  • prior esophageal surgery
  • other serious medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hines VA Medical Center

Maywood, Illinois, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

June 3, 2003

First Posted

June 4, 2003

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations