ClinicalTrials.gov
ClinicalTrials.gov Menu

PPI Versus Placebo in Severe Functional Heartburn

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.
ClinicalTrials.gov Identifier: NCT00222989
Recruitment Status : Withdrawn (Study never started.)
First Posted : September 22, 2005
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Michael M Kline, University of Southern California

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Proton Pump Inhibitors are no better than placebo in relieving GERD symptoms in patients with functional Heartburn.

Condition or disease Intervention/treatment Phase
GERD Drug: PPI Not Applicable

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: PPI Versus Placebo in Severe Functional Heartburn
Study Start Date : October 2003
Estimated Primary Completion Date : December 1, 2100
Estimated Study Completion Date : December 1, 2100

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
no label study
1
 Drug: PPI


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: September 22, 2005    Key Record Dates
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