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NCT03202537 · ClinicalTrials.gov registry record · Early Phase 1
Effectiveness of Physiologic Testing in PPI Non-Responders
A Early Phase 1 study of Gastro Esophageal Reflux, sponsored by Northwestern University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT03202537 is a Early Phase 1 study of Gastro Esophageal Reflux that has completed, run by Northwestern University. The registered enrollment target is 240 participants, below the 12,912-participant average among 7 other Gastro Esophageal Reflux trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03202537, a Early Phase 1 study of Gastro Esophageal Reflux, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study Summary
The prevalence of GERD is estimated to be as high as 20% in the US, and up to 50% remain symptomatic on proton pump inhibitor (PPI) therapy. The clinical approach to understand the mechanism of nonresponse is not standardized, and patients will often undergo various tests: 1) pH-impedance, 2) wireless pH monitoring over 96 hours, 3) high-resolution impedance manometry (HRIM), and 4) mucosal impedance (MI). Controversy exists regarding the best technique, optimal study protocol and treatment approach for the PPI non-responder (PPINR) group, resulting in inappropriate resource utilization and a failure to provide effective personalized care. The first aim is to identify the relevant physiologic parameters of diagnostic tools in their ability to predict PPI requirement. In Aim Two, these results will be applied to guide the formal development of a clinical algorithm for the management of PPINRs with personalized clinical pathways based on mechanism of treatment failure. We will first perform a prospective comparison trial of 240 PPINR subjects at 2 sites over 4 years. Subjects will complete symptom questionnaires and undergo diagnostic testing (pH-impedance on PPI therapy, HRIM, 96-hr wireless pH monitoring off PPI therapy and MI). Those who have a positive pH study and/or resume PPI therapy will receive escalation of therapy with dexlansoprazole. We will compare the ability of 96-hr wireless pH monitoring vs pH impedance to predict PPI requirement and response to dexlansoprazole, respectively. We will explore whether MI is equivalent to 96-hr wireless pH monitoring in predicting PPI requirement. Lastly, we will determine whether HRIM metrics can be utilized to determine reflux burden, mechanism and response to treatment. Next, the investigators will develop quality measures for reflux testing in order to develop a simplified management strategy for the PPINR group. The RAND/UCLA Appropriateness Methodology will be utilized with an expert working group to develop forma
Conditions Studied
Interventions
- DRUG dexlansoprazole
Study Locations (1)
Illinois
- Northwestern Memorial Health Care - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2022-07-31 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03202537
The ClinicalTrials.gov registry entry for NCT03202537 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,912-participant average among 7 other Gastro Esophageal Reflux trials with a reported enrollment target (98% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gastro Esophageal Reflux appearing as the primary indexed condition, and to 1 intervention - of which dexlansoprazole is the first listed.
NCT03202537 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT03202537 about?
NCT03202537 is a clinical study titled "Effectiveness of Physiologic Testing in PPI Non-Responders". The prevalence of GERD is estimated to be as high as 20% in the US, and up to 50% remain symptomatic on proton pump inhibitor (PPI) therapy. The clinical approach to understand the mechanism of nonresponse is not standardized, and patients will often undergo various tests: 1) pH-impedance, 2) wirele...
What is the current status of trial NCT03202537?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 240 participants. The study started on 2017-07-01. Estimated completion is 2022-07-31.
What conditions does trial NCT03202537 study?
This clinical trial studies the following conditions: Gastro Esophageal Reflux.
What interventions are being tested in trial NCT03202537?
The interventions under investigation include: dexlansoprazole (DRUG).
Who is sponsoring clinical trial NCT03202537?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03202537 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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