Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
This is a research study to look at how a new medication compares to standard treatment for reducing acid reflux in patients with Barrett's Esophagus. The study drug is Vonoprazan. This is a pill that is not yet FDA-approved for this purpose in this patient population.
The participants will first continue their current acid-reducing medicine (PPI) once a day for at least 7 days. After that, they will have a test to measure acid levels in their esophagus (food tube) while still taking the PPI medication. After this test, they will stop their current PPI medication and start taking the study drug, Vonoprazan, once a day for 7-28 days. They will then have a second acid test while on the study drug (Vonoprazan).
Before each test, the participants will complete a short questionnaire about their symptoms. The study team will collect their health history, including medical conditions and current medications. After they finish the study drug, they will have a follow-up visit in about 30 days. The participation in the study will then end.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective open-label study of PCAB in adults aged 18 years or older with nondysplastic Barrett's esophagus (NDBE) on maintenance PPI therapy. At the time of enrollment, participants will continue their usual PPI (any brand), standardized to once daily dosing for at least 7 days. After ≥7 days on once daily dosing, participants will undergo ambulatory 24-hour pH impedance testing without interruption of PPI therapy. After pH testing is complete, PPIs will be discontinued and replaced with vonoprazan 20 mg once daily for 7-28 days. After ≥7 days, 24-hour pH impedance testing will be repeated without interruption of vonoprazan therapy. Participants will complete a 30 day safety follow-up after the last dose of vonoprazan. Following completion of the follow-up visit, the patient's participation in the trial will end. Safety will be monitored throughout the study via assessing adverse events and conducting pregnancy and liver function testing.
Participants will complete the validated Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire prior to each pH study to assess symptom burden. Additionally, a health history questionnaire assessing comorbidities, concurrent medications, and past acid suppressive regimens, will be collected.
PPIs and PCABs are FDA-approved but their efficacy has not been compared in the NDBE sub-group enrolled on this study, an open-label prospective cohort without a control arm is the most appropriate and feasible study design as the study aims to compare two treatment methods in the same participant. Because participants will be used as their own comparator, a placebo arm is not needed. Furthermore, maintenance of patients with known BE on a placebo may induce reflux esophagitis.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Shilpa Karanjit, MPH
- Número de teléfono: 919-843-8519
- Correo electrónico: shilpa_karanjit@med.unc.edu
Copia de seguridad de contactos de estudio
- Nombre: Susan E Moist, MPH
- Número de teléfono: 919-918-5900
- Correo electrónico: susan_moist@med.unc.edu
Ubicaciones de estudio
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina at Chapel Hill
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Contacto:
- Shilpa Karanjit, MPH
- Número de teléfono: 919-843-8519
- Correo electrónico: shilpa_karanjit@med.unc.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 18 or older at time of consent.
- Able to read and understand English and provide written informed consent.
- History of Gastroesophageal Reflux Disease (GERD) with or without heartburn.
Diagnosed with nondysplastic Barrett's Esophagus (NBDE) defined as meeting the following within the past 3 years:
- Endoscopically confirmed BE with segment length ≥2 cm (to avoid those with an irregular Z line), and
- Histologic evidence of intestinal metaplasia without dysplasia ("dysplasia" includes indefinite for dysplasia).
- Currently on proton pump inhibitor (PPI) maintenance therapy, defined as PPI prescribed once or twice daily for 3 or more months (defined as 90 days or more) from consent. Any formulation and dosage of PPI will be included, including pantoprazole, omeprazole, esomeprazole, lansoprazole, rabeprazole, dexlansoprazole or their generic equivalents.
- If currently on twice daily PPI, then able to modify PPI regimen to once daily dosing as part of their routine clinical care.
- Ability to take oral medication and willing to adhere to study intervention regimen.
- Willing to follow lifestyle recommendations as outlined in protocol section 5.3
Exclusion Criteria:
- Barrett's Esophagus (BE) with dysplasia (indefinite for dysplasia, or low-grade dysplasia, or high-grade dysplasia) diagnosed within 12 months of study entry.
- Current or prior esophageal adenocarcinoma (EAC).
- Use of other acid suppressive medications.
- H. pylori diagnosis or treatment within the past 6 months prior to study entry.
- History of upper gastrointestinal tract surgery (e.g., esophagectomy or surgery for reflux disease).
Current contraindication to 24hr pH impedance test, including:
- Recent broken nose, nasal surgery, or known deviated septum; or
- Bleeding disorders or those taking certain blood-thinning medications and unable to temporarily discontinue use per current clinical guidance may also be excluded due to increased risk of bleeding during catheter insertion; or
- Individuals with implanted devices like pacemakers or defibrillators.
- Known hypersensitivity or allergic reaction to any component of the study intervention.
- Treatment with another investigational product within 30 days prior to consent.
- Current use of rilpivirine-containing products.
- Pregnant, breastfeeding, or considering becoming pregnant or intending to donate ova during the study and for 30 days after the last dose of study drug.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Proton Pump Inhibitors (PPI) to Potassium-Competitive Acid Blockers (PCABs)
All participants will be enrolled while receiving PPI.
After participant has been on a once daily PPI therapry regimen for at least 7 days, a 24-hour ph impedance test will be conducted while still receiving PPI medication.
Participants will then be switched to PCABs for 7-28 days.
A second 24-hour ph impedance test will be conducted by Day 28 while participants are taking PCABs.
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Potassium -competitive acid blockers (PCABs) are a newer class of acid-suppressing medications more potent than PPIs, with a faster onset and longer duration of action.
PCABs are FDA-approved.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference in percent time with pH<4 during 24-hour pH monitoring on PPI and PCAB therapies. (Normal is <4.0%)
Periodo de tiempo: Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
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24 hour pH impedance testing is a routine clinical care procedure that is often conducted in this patient population as part of their ongoing care and maintenance of their condition to analyze reflux events.
The test is minimally invasive.
Participant's esophageal pH level is measured by completing 24 hour impedance test on visits 2 and 3.
The participants will be on PPI during their first impedance test and they will be on vonoprazan during their second impedance test.
The findings of this test will be used to calculate the difference in percent time with pH<4 during 24-hour pH monitoring.
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Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference in reflux symptom severity scores as measured by the GERD-HRQL questionnaire.
Periodo de tiempo: Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
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The Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire is a patient-reported measure of GERD symptom severity and disease-specific quality of life.
The total score is calculated by summing item scores, yielding a possible range of 0 to 50.
Higher scores represent greater symptom burden and poorer GERD-related quality of life; lower scores represent symptom improvement and better quality of life.
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Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
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Difference in percent time with pH<5 during 24-hour pH monitoring.
Periodo de tiempo: Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
|
24 hour pH impedance testing is a routine clinical care procedure that is often conducted in this patient population as part of their ongoing care and maintenance of their condition to analyze reflux events.
The test is minimally invasive.
Participant's esophageal pH level is measured by completing 24 hour impedance test on visits 2 and 3.
The participants will be on PPI during their first impedance test and they will be on vonoprazan during their second impedance test.
The findings of this test will be used to calculate the difference in percent time with pH<5 during 24-hour pH monitoring.
|
Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
|
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Difference in mean pH during 24-hr pH monitoring.
Periodo de tiempo: Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
|
24 hour pH impedance testing is a routine clinical care procedure that is often conducted in this patient population as part of their ongoing care and maintenance of their condition to analyze reflux events.
The test is minimally invasive.
Participant's esophageal pH level is measured by completing 24 hour impedance test on visits 2 and 3.
The participants will be on PPI during their first impedance test and they will be on vonoprazan during their second impedance test.
The findings of this test will be used to calculate the difference in mean pH during 24-hour pH monitoring.
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Visit 2 (1 day after Baseline through 1 day prior to PCAB switch), Visit 3 (7-28 days after switching to PCAB)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nicholas Shaheen, MD, MPH, UNC Chapel Hill
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25-2665
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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