NCT00539786

Brief Summary

PPI test;empirical trial with high-dose proton-pump inhibitors (PPIs) has been shown to be a sensitive tool for diagnosing patients with GERD. However, this diagnostic strategy has not been well established in patients with extraesophageal manifestation of GERD. In this study, we aim to see the relevance of PPI test in diagnosing GERD in patients with extraesophageal symptoms.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

5.1 years

First QC Date

October 3, 2007

Last Update Submit

May 14, 2014

Conditions

Gastroesophageal Reflux Disease

Keywords

Patients with extraesophageal manifestation of gastroesophageal reflux disease

Outcome Measures

Primary Outcomes (1)

  • Symptom responders after PPI trials

    2 weeks after PPI trials

Interventions

Proton pump inhibitor (rabeprazole)DRUG

Patients receives rabeprazole 20mg AM and 20mg PM for 14 days

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with extraesophageal manifestation symptoms of GERD

You may not qualify if:

  • laryngeal, pharyngeal, liver, lung, renal, or hematological disorders
  • a history of gastrointestinal surgery, and a history of connective tissue disorders.
  • patients with duodenal or gastric ulcers as well as other significant lesions, such as gastric cancer, esophageal cancer, or subepithelial tumors more than 1 cm observed on the upper endoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, Gangnam-gu, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Proton Pump InhibitorsRabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Poong-Lyul Rhee, MD. Ph.D

    Samsung Medical Center, Sungkyunkwan University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tae ggon Kim

CONTACT

+82-2-3410-2975tggo.kim@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2007

First Posted

October 5, 2007

Study Start

March 1, 2006

Primary Completion

April 1, 2011

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations

KR(1)