WithdrawnNot Applicable

A Prospective, Observational Study of the PPI Non-responder

Stopped: insufficient funding

0Started 2017-06-20

Plain-language summary

Gastroesophageal reflux disease (GERD) is a common chronic condition, affecting approximately 20% of the American adult population. Proton pump inhibitors (PPIs) are now the mainstay of medical therapy for symptoms of GERD. Despite their efficacy, several studies have shown that a significant proportion of GERD patients are either partial or non-responders to PPI therapy, defined as symptoms of heartburn and/or regurgitation not relieved by either a standard or double dose of a PPI during a minimum trial of 8 weeks. If GERD symptoms persist, further testing is required. This study will mirror the real world setting to assess the value of published guidelines which recommend specific testing and treatment.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Willing and able to sign informed consent * Persistent GERD symptoms after minimum 8 week trial on daily PPI Exclusion Criteria: * Unwilling to sign informed consent * Prior anti-reflux surgery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objectively evaluate PPI non-responder

Timeframe: 8 Weeks after visit 2

Esophageal acid exposure

Timeframe: 8 Weeks after visit 2

Response to different PPI

Timeframe: 8 Weeks after visit 2

Document the amount of esophageal acid and non-acid exposure in the PPI non-responder patient with proven GERD

Timeframe: 8 Weeks after visit 2

Determine the type, frequency and extent of esophageal motility disorders

Timeframe: 8 Weeks after visit 2

Nepean Dyspepsia Index

Timeframe: 8 Weeks after visit 2

Correlate subjective symptoms of GERD with objective evidence of acid reflux

Timeframe: 8 Weeks after visit 2

Trial details

NCT IDNCT03282084

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-06-15

View on ClinicalTrials.gov More Gastro Esophageal Reflux Disease PPI Non-Responders trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Objectively evaluate PPI non-responder

Timeframe: 8 Weeks after visit 2

Esophageal acid exposure

Timeframe: 8 Weeks after visit 2

Response to different PPI

Timeframe: 8 Weeks after visit 2

Document the amount of esophageal acid and non-acid exposure in the PPI non-responder patient with proven GERD

Timeframe: 8 Weeks after visit 2

Determine the type, frequency and extent of esophageal motility disorders

Timeframe: 8 Weeks after visit 2

Nepean Dyspepsia Index

Timeframe: 8 Weeks after visit 2

Correlate subjective symptoms of GERD with objective evidence of acid reflux

Timeframe: 8 Weeks after visit 2