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This study has been withdrawn prior to enrollment.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

History of Changes

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:

MedlinePlus related topics: Heartburn

U.S. FDA Resources

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


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 Michael M Kline, 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 September 21, 2017

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