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Sublingual Administration of PPI

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ClinicalTrials.gov Identifier: NCT01926600
Recruitment Status : Unknown
Verified August 2013 by Jin Il Kim, The Catholic University of Korea.
Recruitment status was:  Recruiting
First Posted : August 21, 2013
Last Update Posted : August 21, 2013
Information provided by (Responsible Party):

Study Description
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).

Condition or disease
Gastric or Duodenal Ulcer

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
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Study Start Date : August 2013
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : December 2013
Groups and Cohorts

administrated by per oral
Administrated by intravenous
administrated by sublingual

Outcome Measures

Primary Outcome Measures :
  1. Measure 24-hour intragastric pH [ Time Frame: 24 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
3 groups, each group with 20 subject with peptic ulcer ages between 20 to 75

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926600

Contact: Jin Il Kim, MD 82-2-3779-1519 jikim@catholic.ac.kr

Korea, Republic of
St.Mary's Hopspital of the Catholic University Recruiting
Seoul, Korea, Republic of, 150-713
Contact: Jin Il Kim, MD    82-2-3779-1519    jikim@catholic.ac.kr   
Sponsors and Collaborators
The Catholic University of Korea
More Information

Responsible Party: Jin Il Kim, MD, PhD, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01926600     History of Changes
Other Study ID Numbers: 24 hour pH
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by Jin Il Kim, The Catholic University of Korea:
gastric ulcer
duodenal ulcer
re-bleeding rate
intragastric pH
proton pump inhibitor

Additional relevant MeSH terms:
Duodenal Ulcer
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases