NCT00216788

UnknownPhase 1

The Effect of Nexium on Transmucosal Esophageal Leak

Main Line Health Source

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Other study identifiers

Sponsor study identifier

IRUSESOM0388

Study Type

interventional

Estimated enrollment

35

Locations

1 country

Sites

1

Timeline

Study Start

January 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

January 2006

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

In a related study, the investigators have found evidence that patients with Barrett's esophagus have a leak for oral sucrose to leave their upper gastrointestinal tract, enter the blood, and be filtered into urine. The amount of sucrose appearing in an overnight urine sample can be used to indicate the presence of Barrett's esophagus and/or esophagitis in a patient reporting with reflux (GERD) symptoms. The leak is presumably in the Barrett's epithelium itself. This phenomenon will be used to test if a standard 8 week therapy of Nexium in a first-time-presenting GERD patient can reduce the leak as a means of assessing the efficacy of the drug in that patient. The investigators predict that Nexium will reduce leak in esophagitis but not Barrett's patients.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 35 participants
Study completion date: January 2006
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 19, 2005
Actual (reported)
First Posted
September 22, 2005
Actual (reported)
Study Start
January 2006
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
January 2006
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: March 16, 2010
Status Verified: November 2005
Last Update Submitted: March 15, 2010

Conditions

Barrett's Esophagus Esophagitis Reflux

Keywords

SucroseBarrett's esophagusEsophagitisGERDRefluxEsophagusEsomeprazole

Outcome Measures

Primary Outcomes (1)

Urine sucrose level falls below 90 mg after 8 weeks of therapy

Secondary Outcomes (1)

Reduction of patient symptoms consistent with GERD

Interventions

Esomeprazole (Nexium) 40 mg/dayDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients presenting to a general practitioner / internist with symptoms of GERD defined as:
Heartburn - uncomfortable, rising, burning sensation behind the breastbone

Sponsors & Collaborators

Sharpe-Strumia Research Foundation
Othercollaborator
Cancer Research Foundation of America
Othercollaborator
Main Line Health

Study Sites (1)

Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Daniel Lazowick, D.O.CONTACT610-645-6555

Daniel Lazowick, D.O.SUB INVESTIGATOR

MeSH Terms

Conditions

Gastroesophageal RefluxEsophagitisBarrett Esophagus

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisPrecancerous ConditionsNeoplasms

Intervention Hierarchy (Ancestors)

Omeprazole

Study Officials

James M Mullin, Ph.D.
Main Line Health
PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Lazowick, D.O.

CONTACT

610-645-6555

Gambril Murray, M.D.

CONTACT

610-642-6990

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

January 2006

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

January 2006

Estimated (date passed)

NCT03852576

Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus

Phase 1Terminated

NCT01238042

Study To Determine The Maximum Range of Light Doses At Two HPPH Doses With Acceptable Normal Tissue Toxicity For PDT Treatment Of High Grade Dysplasia,CIS or Early Adenocarcinoma In Barrett's Esophagus

Phase 1Completed

NCT01630798

A In-Vivo Esophageal Protocol for Detection of Neoplasia in the Digestive Tract

Phase 1Completed

NCT00284908

Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers

Phase 1Completed

NCT00687245

Pharmacokinetic Study of Esomeprazole Magnesium in Patients 1 to 11 Years-Old With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)

Phase 1Completed

NCT01236443

Study of Photodynamic Therapy (PDT) Using HPPH in Barrett's Esophagus

Phase 1Completed

Regurgitation of gastric acid or sour contents into the mouth

Chest pain atypical for cardiac ischemia and more suggestive of GERD

Symptoms for more than three weeks with no concurrent use of PPI's or H-2 blockers during that time period

A score greater than or equal to 5 on the AstraZeneca RDQ

You may not qualify if:

Any patients presenting with alarm symptoms (GI bleeding, dysphagia, weight loss, abdominal mass, lymphadenopathy, or recurrent vomiting)
Diabetes (type I or II)
Renal insufficiency defined as creatinine \>1.6
Under 18 years of age
Prior surgery on esophagus, stomach or duodenum
History of gastric/duodenal ulcers
History of H. pylori
Known history of Barrett's esophagus (recruited to parallel study)
On Coumadin or Heparin therapy
Chronic upper abdominal pain more consistent with dyspepsia or other diagnoses
Noncompliant patients

Contact the study team to confirm eligibility.

Otherlead

AstraZeneca

Industrycollaborator

2-Pyridinylmethylsulfinylbenzimidazoles

Sulfoxides

Sulfur Compounds

Organic Chemicals

Pyridines

Heterocyclic Compounds, 1-Ring

Heterocyclic Compounds

Benzimidazoles

Heterocyclic Compounds, 2-Ring

Heterocyclic Compounds, Fused-Ring

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

March 16, 2010

Record last verified: 2005-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00216788
Data provider: ClinicalTrials.gov
Source updated: 2010-03-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:28 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations