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PPI Versus Placebo in Severe Functional Heartburn

This study has been withdrawn prior to enrollment.
(Study never started.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00222989
First Posted: September 22, 2005
Last Update Posted: April 14, 2017
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):
Michael M Kline, University of Southern California
  Purpose
Proton Pump Inhibitors are no better than placebo in relieving GERD symptoms in patients with functional Heartburn.

Condition Intervention
GERD Drug: PPI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: PPI Versus Placebo in Severe Functional Heartburn

Resource links provided by NLM:


Further study details as provided by Michael M Kline, University of Southern California:

Primary Outcome Measures:
  • Difference in GERD controll PPI vs Placebo based on a validated GERD questionnarir. [ Time Frame: 1 year ]

Enrollment: 0
Study Start Date: October 2003
Estimated Study Completion Date: December 1, 2100
Estimated Primary Completion Date: December 1, 2100 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
no label study
1
Drug: PPI

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heartburn twice a week for at least 2 years. Normal EGD and 24hr pH study.

Exclusion Criteria:

  • <18yrs of age,pregnant, unable or unwilling to give consent, allergic to PPI, previous gastric or esophageal surgery, past hx of erosive GERD, unwilling or unable to stop acid suppression meds
  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): NCT00222989


Locations
United States, California
USC Keck School of Medicine
LA, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Michael M Kline, MD University of Southern California
  More Information

Responsible Party: Michael M Kline, Associate Professor of Clinical Medicine, University of Southern California
ClinicalTrials.gov Identifier: NCT00222989     History of Changes
Other Study ID Numbers: #026020
474200
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: April 14, 2017
Last Verified: April 2017

Keywords provided by Michael M Kline, University of Southern California:
GERD
PPI
Functional heartburn

Additional relevant MeSH terms:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms