NCT01926600

Brief Summary

Compare 24-hour intragastric pH and therapeutic effectiveness of proton pump inhibitor (PPI) among different administration methods: per oral (PO), intravenous (IV), and sublingual (SL).

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

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

August 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 21, 2013

Status Verified

August 1, 2013

Enrollment Period

3 months

First QC Date

August 19, 2013

Last Update Submit

August 20, 2013

Conditions

Keywords

gastric ulcerduodenal ulcerre-bleeding rateintragastric pHproton pump inhibitor

Outcome Measures

Primary Outcomes (1)

  • Measure 24-hour intragastric pH

    24 hours

Study Arms (3)

PO

administrated by per oral

IV

Administrated by intravenous

SL

administrated by sublingual

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

3 groups, each group with 20 subject with peptic ulcer ages between 20 to 75

You may qualify if:

  • Patients with peptic ulcer disease
  • Age: 20-75 years old
  • Patients who submitted informed consent

You may not qualify if:

  • Peptic ulcer disease with spurting and oozing
  • Shock, hypotension, pregnancy
  • Gastrointestinal malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St.Mary's Hopspital of the Catholic University

Seoul, 150-713, South Korea

RECRUITING

MeSH Terms

Conditions

Duodenal UlcerStomach Ulcer

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

August 21, 2013

Record last verified: 2013-08

Locations