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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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222989

Contacts
Contact: michael M Kline, MD 323 442 5104 ext ------- 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 ext ------     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

No publications provided

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:
Gastroesophageal Reflux
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013