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Sublingual Administration of PPI

NCT ID: NCT01926600

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-12-31

Brief Summary

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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).

Detailed Description

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Intragastric pH and therapeutic effectiveness of PPI was compared among patients given PPI with different administration methods. 24 hour intragastric pH catheter was inserted in stomach of patients with peptic ulcer an hour prior to PPI administration in order to observe the initial change in pH. Three groups of patients were given PPI through per oral, intravenous, and sublingual administration methods. The hypothesis of this study is that sublingual administration will be faster than oral or IV administration in PPI dosing with respect to intragastric pH change and re-bleeding rate.

Conditions

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Gastric or Duodenal Ulcer

Keywords

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gastric ulcer duodenal ulcer re-bleeding rate intragastric pH proton pump inhibitor

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PO

administrated by per oral

No interventions assigned to this group

IV

Administrated by intravenous

No interventions assigned to this group

SL

administrated by sublingual

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Peptic ulcer disease with spurting and oozing
* Shock, hypotension, pregnancy
* Gastrointestinal malignancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Jin Il Kim

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St.Mary's Hopspital of the Catholic University

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jin Il Kim, MD

Role: CONTACT

Phone: 82-2-3779-1519

Email: [email protected]

Facility Contacts

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Jin Il Kim, MD

Role: primary

Other Identifiers

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24 hour pH

Identifier Type: -

Identifier Source: org_study_id