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PPI Versus Placebo in Severe Functional Heartburn

This study has been withdrawn prior to enrollment.
(Study never started.)
Sponsor:
Information provided by (Responsible Party):
Michael M Kline, University of Southern California
ClinicalTrials.gov Identifier:
NCT00222989
First received: September 14, 2005
Last updated: April 12, 2017
Last verified: April 2017
  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 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 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

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
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: 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
Study First Received: September 14, 2005
Last Updated: April 12, 2017

Keywords provided by University of Southern California:
GERD
PPI
Functional heartburn

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

ClinicalTrials.gov processed this record on May 23, 2017