Back to resultsPPI Versus Placebo in Severe Functional Heartburn
Primary Purpose
GERD
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PPI
Sponsored by
About this trial
This is an interventional treatment trial for GERD focused on measuring GERD, PPI, Functional heartburn
Eligibility 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
Sites / Locations
- USC Keck School of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
no label study
Arm Description
1
Outcomes
Primary Outcome Measures
Difference in GERD controll PPI vs Placebo based on a validated GERD questionnarir.
Secondary Outcome Measures
Full Information
NCT ID
NCT00222989
First Posted
September 14, 2005
Last Updated
April 12, 2017
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT00222989
Brief Title
PPI Versus Placebo in Severe Functional Heartburn
Official Title
PPI Versus Placebo in Severe Functional Heartburn
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study never started.
Study Start Date
October 2003 (undefined)
Primary Completion Date
December 1, 2100 (Anticipated)
Study Completion Date
December 1, 2100 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
5. Study Description
Brief Summary
Proton Pump Inhibitors are no better than placebo in relieving GERD symptoms in patients with functional Heartburn.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD
Keywords
GERD, PPI, Functional heartburn
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no label study
Arm Type
Other
Arm Description
1
Intervention Type
Drug
Intervention Name(s)
PPI
Primary Outcome Measure Information:
Title
Difference in GERD controll PPI vs Placebo based on a validated GERD questionnarir.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael M Kline, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Keck School of Medicine
City
LA
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PPI Versus Placebo in Severe Functional Heartburn
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