Gastro Esophageal Reflux Disease PPI Non-RespondersNCT03282084
A Prospective, Observational Study of the PPI Non-responder
An observational study of Gastro Esophageal Reflux Disease PPI Non-Responders, run by Dartmouth-Hitchcock Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro Esophageal Reflux Disease PPI Non-Responders
- What is being tested?
- EGD with biopsy and EGD and impedance-pH study on PPI
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2017to 15 Jun 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with persistent GERD symptoms despite treatment with a minimum of 8 weeks daily PPI.
Who may be able to join
- Willing and able to sign informed consent
- Persistent GERD symptoms after minimum 8 week trial on daily PPI
Who cannot join
- Unwilling to sign informed consent
- Prior anti-reflux surgery
About this study
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.
Read the detailed description
Gastroesophageal reflux disease (GERD) is a common chronic condition, affecting approximately 20% of the American adult population. Gastroesophageal reflux disease is characterized by a number of symptoms, the 2 most common being frequent heartburn and acid regurgitation. Untreated or undertreated gastroesophageal reflux (GER) can lead to complications including esophageal erosions, strictures, esophageal adenocarcinoma, and impaired quality of life.
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. A review of 19 studies looking at GERD patients treated with PPIs found an overall prevalence of partial and non-responders of up to 45% in observational studies. Non-randomized studies revealed a prevalence of 17% when defined as "persisting troublesome heartburn" and 28% when defined as troublesome regurgitation, while randomized studies revealed prevalence rates of 32% and 28%, respectively.
Current guidelines recommend an 8-week trial of a daily PPI for the treatment of symptoms thought secondary to GERD. However, if GERD symptoms persist despite taking the PPI correctly, then testing is required. National guidelines recommend that patients with GERD symptoms who have failed empiric therapy with a PPI undergo upper endoscopy (EGD). This recommendation is based on data showing that the PPI non-responsive patient may have a disorder (e.g., peptic ulcer disease, dyspepsia, eosinophilic esophagitis, cancer) that can only be identified by EGD. During upper endoscopy a 48-hour wireless pH capsule can be placed to measure acid reflux into the distal esophagus. This recommended practice has been shown to be cost effective. If the 48 hour wireless pH capsule study documents pathologic acid reflux, then the diagnosis of acid reflux is confirmed and the patient should be restarted on a PPI with appropriate counseling regarding how to take a PPI properly. Switching the patient to an alternative PPI is a reasonable strategy, as some patients respond better to one PPI than another . In addition, during this index endoscopy, biopsies of the esophagus should be taken to rule out eosinophilic esophagitis.
Some patients in clinical practice have previously undergone testing due to their GERD symptoms. In patients with proven GERD (e.g., prior EGD with LA Grade B-D esophagitis, known Barrett's esophagus, prior positive pH tests either on or off PPI therapy) who continue to have GERD symptoms on a daily PPI, guidelines recommend that impedance pH-testing be performed on daily PPI therapy. Guidelines do not recommend testing on b.i.d. PPI therapy, since most patients with GERD do not require twice-daily PPI therapy. In this patient population (the PPI non-responder with proven GERD), impedance-pH testing is preferable to 48-hour wireless pH capsule testing as non-acid reflux can be detected as well. To be cost effective, and to reduce the number of unnecessary EGDs, if upper endoscopy was recently performed, then impedance-pH testing can be performed after accurate localization of the lower esophageal sphincter using high resolution esophageal manometry (HREM). If the impedance-pH test is negative (normal) on daily PPI therapy, demonstrating that acid reflux is controlled, then a second diagnosis should to be considered (e.g., functional dyspepsia, gastroparesis, an esophageal motility disorder). If impedance-pH monitoring demonstrates abnormal acid reflux on daily PPI therapy, then guidelines recommend that the PPI dose should be increased to twice daily and symptoms reassessed at 8 weeks.
The clinical treatment pathways outlined above are based on national guidelines and are promoted as standards of care. However, despite the fact that these guidelines recommend distinct diagnostic pathways for patients who are non-responsive to PPIs, there is little "real-world" data to support these guidelines and no information about the outcomes of these patients who are treated using these diagnostic pathways. The simple goal of this study is to identify the PPI non-responder patient with GERD symptoms and identify and quantify the type, number and outcomes of diagnostic tests recommended by national guidelines.
- Being tested
- EGD with biopsy, EGD and impedance-pH study on PPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGD with biopsyDiagnostic test
Also called Wireless pH Capsule
Stop PPI and schedule for EGD with biopsy and Wireless pH capsule testing for 7-10 days later. Consider gastric emptying scan or high resolution esophageal manometry
EGD and impedance-pH study on PPIDiagnostic test
Continue PPI and schedule EGD and Impedance-pH study on PPI. Consider gastric emptying scan or high resolution esophageal manometry
| Study group | Role | What they receive |
|---|---|---|
| Unproven GERD | Subjects with no prior testing, normal prior EGD or prior LA Grade A esophagitis Receives: Diagnostic Test: EGD with biopsy | |
| Proven GERD | LA Grade B-D esophagitis, long-segment Barrett's, prior positive pH study Receives: Diagnostic Test: EGD and impedance-pH study on PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectively evaluate PPI non-responder
Number of participants with unproven GERD who have reflux esophagitis and eosinophile esophagitis
Measured: 8 Weeks after visit 2
Esophageal acid exposure
Number and extent of abnormal acid exposure as measured by pH-metry (Bravo capsule) off PPI.
Measured: 8 Weeks after visit 2
Response to different PPI
Percentage of patients with GERD who fail standard PPI Therapy as documented by wireless pH capsule testing that then respond to an alternative PPI
Measured: 8 Weeks after visit 2
Document the amount of esophageal acid and non-acid exposure in the PPI non-responder patient with proven GERD
Amount of acid and non-acid exposure in PPI-nonresponder patients with proven GERD as measured by impedance-pH testing on daily PPI therapy.
Measured: 8 Weeks after visit 2
Determine the type, frequency and extent of esophageal motility disorders
Determine the type, frequency and extent of esophageal motility disorders using HREM (high resolution esophageal manometry) in patients with persistent GERD symptoms despite PPI therapy
Measured: 8 Weeks after visit 2
Nepean Dyspepsia Index
Using a validated questionnaire determine the prevalence and severity of functional dyspepsia in patients presenting with GERD symptoms using the Nepean Dyspepsia Index.
Measured: 8 Weeks after visit 2
Correlate subjective symptoms of GERD with objective evidence of acid reflux
Comparison of symptomatic GERD based on GERD-Q validated questionnaire and pH testing
Measured: 8 Weeks after visit 2
Assess overlapping symptoms of dysphagia and GERD
Assess overlapping symptoms of dysphagia in patients with GERD symptoms who do not respond to empiric PPI therapy using a validated dysphagia questionnaire.
Measured: 8 Weeks after visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start20 Jun 2017
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Why it stopped: insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Gastro Esophageal Reflux Disease PPI Non-RespondersStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian E Lacy, MD, PhD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282084
- Sponsor's protocol ID
- D17109
- Status last verified
- Mar 2019
- First submitted
- 9 Jun 2017
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.
PubMed 9136821Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976 Nov;21(11):953-6. doi: 10.1007/BF01071906.
PubMed 984016El-Serag H, Becher A, Jones R. Systematic review: persistent reflux symptoms on proton pump inhibitor therapy in primary care and community studies. Aliment Pharmacol Ther. 2010 Sep;32(6):720-37. doi: 10.1111/j.1365-2036.2010.04406.x.
PubMed 20662774Richter JE. How to manage refractory GERD. Nat Clin Pract Gastroenterol Hepatol. 2007 Dec;4(12):658-64. doi: 10.1038/ncpgasthep0979.
PubMed 18043675Cicala M, Emerenziani S, Guarino MP, Ribolsi M. Proton pump inhibitor resistance, the real challenge in gastro-esophageal reflux disease. World J Gastroenterol. 2013 Oct 21;19(39):6529-35. doi: 10.3748/wjg.v19.i39.6529.
PubMed 24151377Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available.
PubMed 23419381Dickman R, Boaz M, Aizic S, Beniashvili Z, Fass R, Niv Y. Comparison of clinical characteristics of patients with gastroesophageal reflux disease who failed proton pump inhibitor therapy versus those who fully responded. J Neurogastroenterol Motil. 2011 Oct;17(4):387-94. doi: 10.5056/jnm.2011.17.4.387. Epub 2011 Oct 31.
PubMed 22148108Lee WC, Yeh YC, Lacy BE, Pandolfino JE, Brill JV, Weinstein ML, Carlson AM, Williams MJ, Wittek MR, Pashos CL. Timely confirmation of gastro-esophageal reflux disease via pH monitoring: estimating budget impact on managed care organizations. Curr Med Res Opin. 2008 May;24(5):1317-27. doi: 10.1185/030079908x280680. Epub 2008 Mar 27.
PubMed 18377705Miller SM, Goldstein JL, Gerson LB. Cost-effectiveness model of endoscopic biopsy for eosinophilic esophagitis in patients with refractory GERD. Am J Gastroenterol. 2011 Aug;106(8):1439-45. doi: 10.1038/ajg.2011.94. Epub 2011 Mar 29.
PubMed 21448144Charbel S, Khandwala F, Vaezi MF. The role of esophageal pH monitoring in symptomatic patients on PPI therapy. Am J Gastroenterol. 2005 Feb;100(2):283-9. doi: 10.1111/j.1572-0241.2005.41210.x.
PubMed 15667483Mainie I, Tutuian R, Shay S, Vela M, Zhang X, Sifrim D, Castell DO. Acid and non-acid reflux in patients with persistent symptoms despite acid suppressive therapy: a multicentre study using combined ambulatory impedance-pH monitoring. Gut. 2006 Oct;55(10):1398-402. doi: 10.1136/gut.2005.087668. Epub 2006 Mar 23.
PubMed 16556669Quigley EM, Lacy BE. Overlap of functional dyspepsia and GERD--diagnostic and treatment implications. Nat Rev Gastroenterol Hepatol. 2013 Mar;10(3):175-86. doi: 10.1038/nrgastro.2012.253. Epub 2013 Jan 8.
PubMed 23296247Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.
PubMed 23147521
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study of the PPI Non-responder
- ClinicalTrials.gov ID
- NCT03282084
- Acronym / sponsor ID
- D17109
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: insufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 13 Sep 2017 (actual)
- 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.
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.
Detailed description
Gastroesophageal reflux disease (GERD) is a common chronic condition, affecting approximately 20% of the American adult population. Gastroesophageal reflux disease is characterized by a number of symptoms, the 2 most common being frequent heartburn and acid regurgitation. Untreated or undertreated gastroesophageal reflux (GER) can lead to complications including esophageal erosions, strictures, esophageal adenocarcinoma, and impaired quality of life.
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. A review of 19 studies looking at GERD patients treated with PPIs found an overall prevalence of partial and non-responders of up to 45% in observational studies. Non-randomized studies revealed a prevalence of 17% when defined as "persisting troublesome heartburn" and 28% when defined as troublesome regurgitation, while randomized studies revealed prevalence rates of 32% and 28%, respectively.
Current guidelines recommend an 8-week trial of a daily PPI for the treatment of symptoms thought secondary to GERD. However, if GERD symptoms persist despite taking the PPI correctly, then testing is required. National guidelines recommend that patients with GERD symptoms who have failed empiric therapy with a PPI undergo upper endoscopy (EGD). This recommendation is based on data showing that the PPI non-responsive patient may have a disorder (e.g., peptic ulcer disease, dyspepsia, eosinophilic esophagitis, cancer) that can only be identified by EGD. During upper endoscopy a 48-hour wireless pH capsule can be placed to measure acid reflux into the distal esophagus. This recommended practice has been shown to be cost effective. If the 48 hour wireless pH capsule study documents pathologic acid reflux, then the diagnosis of acid reflux is confirmed and the patient should be restarted on a PPI with appropriate counseling regarding how to take a PPI properly. Switching the patient to an alternative PPI is a reasonable strategy, as some patients respond better to one PPI than another . In addition, during this index endoscopy, biopsies of the esophagus should be taken to rule out eosinophilic esophagitis.
Some patients in clinical practice have previously undergone testing due to their GERD symptoms. In patients with proven GERD (e.g., prior EGD with LA Grade B-D esophagitis, known Barrett's esophagus, prior positive pH tests either on or off PPI therapy) who continue to have GERD symptoms on a daily PPI, guidelines recommend that impedance pH-testing be performed on daily PPI therapy. Guidelines do not recommend testing on b.i.d. PPI therapy, since most patients with GERD do not require twice-daily PPI therapy. In this patient population (the PPI non-responder with proven GERD), impedance-pH testing is preferable to 48-hour wireless pH capsule testing as non-acid reflux can be detected as well. To be cost effective, and to reduce the number of unnecessary EGDs, if upper endoscopy was recently performed, then impedance-pH testing can be performed after accurate localization of the lower esophageal sphincter using high resolution esophageal manometry (HREM). If the impedance-pH test is negative (normal) on daily PPI therapy, demonstrating that acid reflux is controlled, then a second diagnosis should to be considered (e.g., functional dyspepsia, gastroparesis, an esophageal motility disorder). If impedance-pH monitoring demonstrates abnormal acid reflux on daily PPI therapy, then guidelines recommend that the PPI dose should be increased to twice daily and symptoms reassessed at 8 weeks.
The clinical treatment pathways outlined above are based on national guidelines and are promoted as standards of care. However, despite the fact that these guidelines recommend distinct diagnostic pathways for patients who are non-responsive to PPIs, there is little "real-world" data to support these guidelines and no information about the outcomes of these patients who are treated using these diagnostic pathways. The simple goal of this study is to identify the PPI non-responder patient with GERD symptoms and identify and quantify the type, number and outcomes of diagnostic tests recommended by national guidelines.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unproven GERD | – | Diagnostic Test: EGD with biopsySubjects with no prior testing, normal prior EGD or prior LA Grade A esophagitis |
| Proven GERD | – | Diagnostic Test: EGD and impedance-pH study on PPILA Grade B-D esophagitis, long-segment Barrett's, prior positive pH study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with persistent GERD symptoms despite treatment with a minimum of 8 weeks daily PPI.
Key inclusion criteria (2 listed)
- Willing and able to sign informed consent
- Persistent GERD symptoms after minimum 8 week trial on daily PPI
Key exclusion criteria (2 listed)
- Unwilling to sign informed consent
- Prior anti-reflux surgery
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 |
|---|---|---|
| EGD with biopsyAlso: Wireless pH CapsuleStop PPI and schedule for EGD with biopsy and Wireless pH capsule testing for 7-10 days later. Consider gastric emptying scan or high resolution esophageal manometry | Diagnostic test | Unproven GERD |
| EGD and impedance-pH study on PPIContinue PPI and schedule EGD and Impedance-pH study on PPI. Consider gastric emptying scan or high resolution esophageal manometry | Diagnostic test | Proven GERD |
Primary outcome
Objectively evaluate PPI non-responder
Time frame: 8 Weeks after visit 2
Number of participants with unproven GERD who have reflux esophagitis and eosinophile esophagitis
Esophageal acid exposure
Time frame: 8 Weeks after visit 2
Number and extent of abnormal acid exposure as measured by pH-metry (Bravo capsule) off PPI.
Response to different PPI
Time frame: 8 Weeks after visit 2
Percentage of patients with GERD who fail standard PPI Therapy as documented by wireless pH capsule testing that then respond to an alternative PPI
Document the amount of esophageal acid and non-acid exposure in the PPI non-responder patient with proven GERD
Time frame: 8 Weeks after visit 2
Amount of acid and non-acid exposure in PPI-nonresponder patients with proven GERD as measured by impedance-pH testing on daily PPI therapy.
Determine the type, frequency and extent of esophageal motility disorders
Time frame: 8 Weeks after visit 2
Determine the type, frequency and extent of esophageal motility disorders using HREM (high resolution esophageal manometry) in patients with persistent GERD symptoms despite PPI therapy
Nepean Dyspepsia Index
Time frame: 8 Weeks after visit 2
Using a validated questionnaire determine the prevalence and severity of functional dyspepsia in patients presenting with GERD symptoms using the Nepean Dyspepsia Index.
Correlate subjective symptoms of GERD with objective evidence of acid reflux
Time frame: 8 Weeks after visit 2
Comparison of symptomatic GERD based on GERD-Q validated questionnaire and pH testing
Assess overlapping symptoms of dysphagia and GERD
Time frame: 8 Weeks after visit 2
Assess overlapping symptoms of dysphagia in patients with GERD symptoms who do not respond to empiric PPI therapy using a validated dysphagia questionnaire.
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 2 Apr 2019.
- Background: PubMed 9136821Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.
- Background: PubMed 984016Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976 Nov;21(11):953-6. doi: 10.1007/BF01071906.
- Background: PubMed 20662774El-Serag H, Becher A, Jones R. Systematic review: persistent reflux symptoms on proton pump inhibitor therapy in primary care and community studies. Aliment Pharmacol Ther. 2010 Sep;32(6):720-37. doi: 10.1111/j.1365-2036.2010.04406.x.
- Background: PubMed 18043675Richter JE. How to manage refractory GERD. Nat Clin Pract Gastroenterol Hepatol. 2007 Dec;4(12):658-64. doi: 10.1038/ncpgasthep0979.
- Background: PubMed 24151377Cicala M, Emerenziani S, Guarino MP, Ribolsi M. Proton pump inhibitor resistance, the real challenge in gastro-esophageal reflux disease. World J Gastroenterol. 2013 Oct 21;19(39):6529-35. doi: 10.3748/wjg.v19.i39.6529.
- Background: PubMed 23419381Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available.
- Background: PubMed 22148108Dickman R, Boaz M, Aizic S, Beniashvili Z, Fass R, Niv Y. Comparison of clinical characteristics of patients with gastroesophageal reflux disease who failed proton pump inhibitor therapy versus those who fully responded. J Neurogastroenterol Motil. 2011 Oct;17(4):387-94. doi: 10.5056/jnm.2011.17.4.387. Epub 2011 Oct 31.
- Background: PubMed 18377705Lee WC, Yeh YC, Lacy BE, Pandolfino JE, Brill JV, Weinstein ML, Carlson AM, Williams MJ, Wittek MR, Pashos CL. Timely confirmation of gastro-esophageal reflux disease via pH monitoring: estimating budget impact on managed care organizations. Curr Med Res Opin. 2008 May;24(5):1317-27. doi: 10.1185/030079908x280680. Epub 2008 Mar 27.
- Background: PubMed 21448144Miller SM, Goldstein JL, Gerson LB. Cost-effectiveness model of endoscopic biopsy for eosinophilic esophagitis in patients with refractory GERD. Am J Gastroenterol. 2011 Aug;106(8):1439-45. doi: 10.1038/ajg.2011.94. Epub 2011 Mar 29.
- Background: PubMed 15667483Charbel S, Khandwala F, Vaezi MF. The role of esophageal pH monitoring in symptomatic patients on PPI therapy. Am J Gastroenterol. 2005 Feb;100(2):283-9. doi: 10.1111/j.1572-0241.2005.41210.x.
- Background: PubMed 16556669Mainie I, Tutuian R, Shay S, Vela M, Zhang X, Sifrim D, Castell DO. Acid and non-acid reflux in patients with persistent symptoms despite acid suppressive therapy: a multicentre study using combined ambulatory impedance-pH monitoring. Gut. 2006 Oct;55(10):1398-402. doi: 10.1136/gut.2005.087668. Epub 2006 Mar 23.
- Background: PubMed 23296247Quigley EM, Lacy BE. Overlap of functional dyspepsia and GERD--diagnostic and treatment implications. Nat Rev Gastroenterol Hepatol. 2013 Mar;10(3):175-86. doi: 10.1038/nrgastro.2012.253. Epub 2013 Jan 8.
- Individual participant dataSharing planned: No
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.
Brian E Lacy, MD, PhD principal investigator
Dartmouth-Hitchcock Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro Esophageal Reflux Disease PPI Non-Responders, run by Dartmouth-Hitchcock Medical Center.
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 2 inclusion and 2 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 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Objectively evaluate PPI non-responder (time frame: 8 Weeks after visit 2). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282084, which also lists 13 linked publications.
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 2 Apr 2019.