NCT00222989

Brief Summary

Proton Pump Inhibitors are no better than placebo in relieving GERD symptoms in patients with functional Heartburn.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
908mo left

Started Oct 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Oct 2003Dec 2100

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
95.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2100

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2100

Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

97.2 years

First QC Date

September 14, 2005

Last Update Submit

April 12, 2017

Conditions

GERD

Keywords

GERDPPIFunctional heartburn

Outcome Measures

Primary Outcomes (1)

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

    1 year

Study Arms (1)

no label study

OTHER

1

Drug: PPI

Interventions

PPIDRUG
no label study

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heartburn twice a week for at least 2 years. Normal EGD and 24hr pH study.

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Keck School of Medicine

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Michael M Kline, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Medicine

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

October 1, 2003

Primary Completion (Estimated)

December 1, 2100

Study Completion (Estimated)

December 1, 2100

Last Updated

April 14, 2017

Record last verified: 2017-04

Locations

US(1)