Sublingual Administration of PPI

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2013 by The Catholic University of Korea.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Jin Il Kim, The Catholic University of Korea Identifier:
First received: August 19, 2013
Last updated: August 20, 2013
Last verified: August 2013
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).

Gastric or Duodenal Ulcer

Study Type: Observational
Study Design: 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

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Measure 24-hour intragastric pH [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
administrated by per oral
Administrated by intravenous
administrated by sublingual

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.

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01926600

Contact: Jin Il Kim, MD 82-2-3779-1519

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   
Sponsors and Collaborators
The Catholic University of Korea
  More Information

Responsible Party: Jin Il Kim, MD, PhD, The Catholic University of Korea Identifier: NCT01926600     History of Changes
Other Study ID Numbers: 24 hour pH 
Study First Received: August 19, 2013
Last Updated: August 20, 2013
Health Authority: Korea: Ministry for Health and Welfare

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

Additional relevant MeSH terms:
Duodenal Ulcer
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Intestinal Diseases
Peptic Ulcer
Stomach Diseases processed this record on May 26, 2016