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PPI Versus Placebo in Severe Functional Heartburn

This study has been withdrawn prior to enrollment.
(Study never started.)
Information provided by (Responsible Party):
Michael M Kline, University of Southern California Identifier:
First received: September 14, 2005
Last updated: April 12, 2017
Last verified: April 2017
Proton Pump Inhibitors are no better than placebo in relieving GERD symptoms in patients with functional Heartburn.

Condition Intervention
Drug: PPI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (masked roles unspecified)
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
Drug: PPI


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

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
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Please refer to this study by its identifier: NCT00222989

United States, California
USC Keck School of Medicine
LA, California, United States, 90033
Sponsors and Collaborators
University of Southern California
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 Identifier: NCT00222989     History of Changes
Other Study ID Numbers: #026020
Study First Received: September 14, 2005
Last Updated: April 12, 2017

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

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on May 25, 2017