GERDNCT00222989
PPI Versus Placebo in Severe Functional Heartburn
A study testing PPI in people with GERD, run by University of Southern California at 1 site in United States.
Trial summary
Proton Pump Inhibitors are no better than placebo in relieving GERD symptoms in patients with functional Heartburn. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- GERD
- What is being tested?
- PPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to 1 Dec 2100
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heartburn twice a week for at least 2 years. Normal EGD and 24hr pH study.
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Keck School of Medicine
Los Angeles, California, 90033
About this study
Proton Pump Inhibitors are no better than placebo in relieving GERD symptoms in patients with functional Heartburn.
- Conditions
- GERD
- Being tested
- PPI
- Keywords
- GERD, PPI, Functional heartburn
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPIDrug
| Study group | Role | What they receive |
|---|---|---|
| no label study | Other | 1 Receives: Drug: PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in GERD controll PPI vs Placebo based on a validated GERD questionnarir.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2003
- Primary completion1 Dec 2100 (estimated)
- Study completion1 Dec 2100 (estimated)
Why it stopped: Study never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael M Kline, University of Southern California
- Investigators
- Michael M Kline, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222989
- Sponsor's protocol ID
- #026020
- Other IDs
- 474200
- Status last verified
- Apr 2017
- First submitted
- 14 Sep 2005
- Last updated
- 14 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPI Versus Placebo in Severe Functional Heartburn
- ClinicalTrials.gov ID
- NCT00222989
- Acronym / sponsor ID
- #026020
- Conditions
- GERD
- Keywords
- GERD, PPI, Functional heartburn
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- 1 Dec 2100 (estimated)
- Study completion
- 1 Dec 2100 (estimated)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Proton Pump Inhibitors are no better than placebo in relieving GERD symptoms in patients with functional Heartburn.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no label study | Other | Drug: PPI1 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Heartburn twice a week for at least 2 years. Normal EGD and 24hr pH study.
Key exclusion criteria (1 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPI | Drug | no label study |
Primary outcome
Difference in GERD controll PPI vs Placebo based on a validated GERD questionnarir.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael M Kline, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPI in people with GERD, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in GERD controll PPI vs Placebo based on a validated GERD questionnarir. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.