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A Prospective, Observational Study of the PPI Non-responder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03282084
Recruitment Status : Withdrawn (insufficient funding)
First Posted : September 13, 2017
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief 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.

Condition or disease Intervention/treatment
Gastro Esophageal Reflux Disease PPI Non-Responders Diagnostic Test: EGD with biopsy Diagnostic Test: EGD and impedance-pH study on PPI

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Prospective, Observational Study of the PPI Non-responder
Actual Study Start Date : June 20, 2017
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort Intervention/treatment
Unproven GERD
Subjects with no prior testing, normal prior EGD or prior LA Grade A esophagitis
Diagnostic Test: EGD with biopsy
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
Other Name: Wireless pH Capsule

Proven GERD
LA Grade B-D esophagitis, long-segment Barrett's, prior positive pH study
Diagnostic Test: EGD and impedance-pH study on PPI
Continue PPI and schedule EGD and Impedance-pH study on PPI. Consider gastric emptying scan or high resolution esophageal manometry




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with persistent GERD symptoms despite treatment with a minimum of 8 weeks daily PPI.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282084


Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Brian E Lacy, MD, PhD Dartmouth-Hitchcock Medical Center
Publications:

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Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03282084    
Other Study ID Numbers: D17109
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases