NCT00730106

Brief Summary

Gastroesophageal reflux disease (GERD) is diagnosed on the basis of characteristic reflux symptoms (i.e. troublesome heartburn and/or acid regurgitation). Empirical therapy without diagnostic endoscopy is suggested for those GERD patients presenting without alarm symptoms in Western countries. Whether such "treating instead of testing" strategy should be applied in Asia, an area with higher prevalence of Helicobacter pylori and gastric cancer, remains uninvestigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 19, 2010

Status Verified

October 1, 2010

Enrollment Period

1.2 years

First QC Date

August 4, 2008

Last Update Submit

October 18, 2010

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux diseaseAlarm symptomsGastrointestinal endoscopy

Outcome Measures

Primary Outcomes (1)

  • Pre-defined significant upper digestive endoscopic findings

    within one month after the endoscopy examination

Study Arms (2)

1

Patients with pre-defined alarm symptoms

2

Patients without pre-defined alarm symptoms

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult outpatients with characteristic GERD symptoms, in a district general hospital

You may qualify if:

  • outpatients
  • chief complaints of characteristic GERD symptoms (heart burn or acid regurgitation), evaluated by standard questionnaire
  • undergo upper digestive endoscopy

You may not qualify if:

  • age less than 18 years old or more than 90 years old
  • unable to complete upper endoscopy
  • known diagnosis of gastroesophageal malignancy
  • follow-up visit for known gastroesophageal lesion identified by previous upper endoscopy
  • failure to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lotung Poh-Ai Hospital

Lotung Town, Ilan County, 265, Taiwan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Yao-Chun Hsu, M.D.

    Lotung Poh-Ai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 8, 2008

Study Start

May 1, 2008

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

October 19, 2010

Record last verified: 2010-10

Locations

TW(1)