Sublingual Administration of PPI

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by The Catholic University of Korea
Sponsor:
Information provided by (Responsible Party):
Jin Il Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01926600
First received: August 19, 2013
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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
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)
Groups/Cohorts
PO
administrated by per oral
IV
Administrated by intravenous
SL
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.

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01926600

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

Locations
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

No publications provided

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
Study First Received: August 19, 2013
Last Updated: August 20, 2013
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

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
Ulcer
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014