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Sublingual Administration of PPI

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Jin Il Kim, The Catholic University of Korea.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01926600
First Posted: August 21, 2013
Last Update Posted: August 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jin Il Kim, The Catholic University of Korea
  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 Jin Il Kim, The Catholic University of Korea:

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

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

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
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
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


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

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 Submitted: August 19, 2013
First Posted: August 21, 2013
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