NCT00471029

Brief Summary

The purpose of this study is to compare the gastric acid suppression profile among different regimen (Oral Vs Intravenous)of administration of proton pump inhibitor - Esomeprazole by 24hours intragastric pH monitoring.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 9, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 9, 2007

Status Verified

May 1, 2007

First QC Date

May 8, 2007

Last Update Submit

May 8, 2007

Conditions

Peptic Ulcer

Keywords

pH study, peptic ulcer, proton pump inhibitor

Outcome Measures

Primary Outcomes (1)

  • percentage of time intragstric pH > 6 and > 4

    24hours after endoscopy

Secondary Outcomes (2)

  • Median intragastric pH

    24hours after endoscopy

  • time to attain intragastric pH 4 & 6

    24hours after endoscopy

Interventions

esomeprazoleDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with non-bleeding peptic ulcer which do not require endoscopic therapy.
  • Chinese, Age ³18 and \<90
  • Provision of an informed written consent signed by the patient.

You may not qualify if:

  • Treatment of antisecretory drugs during the preceding 4 weeks
  • The present inter-current ulcer complication (gastric outlet obstruction or ulcer perforation)
  • Presence of esophageal / gastric varices
  • aspirin or NSAID user
  • Pregnancy
  • Age \<18 or \>90
  • Moribund patients, patients with severe liver or renal disease
  • Known sensitivity to proton pump inhibitors
  • Previous gastric surgery (except simple patch repair)
  • Patient unable to give written consent
  • Special population, e.g. prisoner, mentally disabled, investigators' student or employees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Simon K.H. Wong, MBChB, FRCSEd, FHKAM

    Pamela Youde Nethersole Hospital - Surgery

    PRINCIPAL INVESTIGATOR

  • Michael K.W. Li, MD

    PYNEH

    STUDY CHAIR

Central Study Contacts

Simon K.H. Wong, MBChB, FRCSEd, FHKAM

CONTACT

852-25956416wongkhmo@netvigator.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2007

First Posted

May 9, 2007

Study Start

September 1, 2005

Study Completion

September 1, 2007

Last Updated

May 9, 2007

Record last verified: 2007-05

Locations

CN(1)