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PPI Versus Placebo in Severe Functional Heartburn

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by University of Southern California.
Recruitment status was:  Recruiting
Information provided by:
University of Southern California Identifier:
First received: September 14, 2005
Last updated: September 13, 2006
Last verified: September 2006
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: Allocation: Randomized
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:

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

Ages Eligible for Study:   18 Years and older   (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
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 identifier: NCT00222989

Contact: michael M Kline, MD 323 442 5104

United States, California
USC Keck School of Medicine Recruiting
LA, California, United States, 90033
Contact: Michael M Kline, MD    323-442-5104   
Principal Investigator: Michael M Kline, MD         
Sponsors and Collaborators
University of Southern California
Principal Investigator: Michael M Kline, MD University of Southern California
  More Information Identifier: NCT00222989     History of Changes
Other Study ID Numbers: #026020
Study First Received: September 14, 2005
Last Updated: September 13, 2006

Keywords provided by University of Southern California:
Functional heartburn

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on March 28, 2017