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Clinical Trials/NCT01926600
NCT01926600UnknownNot Applicable

Sublingual Administration is More Fast Than Oral or IV Administration in PPI Dosing With Respect to Intragastric pH and Therapeutic Effectiveness: a Prospective, Randomized, Controlled Trial

The Catholic University of Korea1 site in 1 country60 target enrollmentStarted: August 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Measure 24-hour intragastric pH

Study Overview

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).

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Measure 24-hour intragastric pH

Time Frame: 24 hours

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jin Il Kim

MD, PhD

The Catholic University of Korea

Study Sites (1)

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