PPI Versus Placebo in Severe Functional Heartburn

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2006 by University of Southern California.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University of Southern California

ClinicalTrials.gov Identifier:

NCT00222989

First received: September 14, 2005

Last updated: September 13, 2006

Last verified: September 2006

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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind 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 University of Southern California:

Primary Outcome Measures:

Difference in GERD controll PPI vs Placebo based on a validated GERD questionnarir.


Estimated Enrollment:	60
Study Start Date:	October 2003

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Contacts


Contact: michael M Kline, MD	323 442 5104	mkline@usc.edu

Locations


United States, California
USC Keck School of Medicine	Recruiting
LA, California, United States, 90033
Contact: Michael M Kline, MD 323-442-5104 mkline@usc.edu
Principal Investigator: Michael M Kline, MD

Sponsors and Collaborators

University of Southern California

Investigators


Principal Investigator:	Michael M Kline, MD	University of Southern California

More Information


ClinicalTrials.gov Identifier:	NCT00222989 History of Changes
Other Study ID Numbers:	#026020 474200
Study First Received:	September 14, 2005
Last Updated:	September 13, 2006
Health Authority:	United States: Institutional Review Board

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 September 30, 2016

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