Sublingual Administration of PPI

Gastric or Duodenal Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01926600
• Other study ID #: 24 hour pH
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2013
• Last updated: August 20, 2013
• Start date: August 2013
• Est. completion date: December 2013

Study information

• Verified date: August 2013
• Source: The Catholic University of Korea
• Contact: Jin Il Kim, MD
• Phone: 82-2-3779-1519
• Email: jikim[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Duodenal Ulcer
• Gastric or Duodenal Ulcer

Locations

Country	Name	City	State
Korea, Republic of	St.Mary's Hopspital of the Catholic University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure 24-hour intragastric pH		24 hours	No