Sublingual Administration of PPI

• Conditions: Gastric or Duodenal Ulcer

• Registration Number: NCT01926600
• Lead Sponsor: The Catholic University of Korea

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 Timeline

• Status Verified: 2013-08
• Study Start: 2013-08
• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-20
• Last Update Submitted: 2013-08-20
• Study First Posted: 2013-08-21
• Last Update Posted: 2013-08-21
• Primary Completion: 2013-11
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure 24-hour intragastric pH	24 hours

Trial Locations

Locations (1)

St.Mary's Hopspital of the Catholic University; 🇰🇷 Seoul, Korea, Republic of