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Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features

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ClinicalTrials.gov Identifier: NCT04028466
Recruitment Status : Recruiting
First Posted : July 22, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Nicodemus Ong, St. Luke's Medical Center, Philippines

Brief Summary:
Gastroesophageal reflux disease is a commonly encountered disorder in daily practice. Proton pump inhibitor therapy has been the cornerstone of treatment for decades. Although it has been proven to be highly effective, there is still room for improvement. A local study showed that only 57.3% of subjects are asymptomatic after 4 weeks treatment with rabeprazole. Recently a new drug was developed with better absorption, higher bioavailability, more sustained increased pH in the stomach and more targeted action to the H-K ATPase pump. Vonoprazan, belongs to a new class of acid suppressant medications, the potassium-competitive acid blocker (P-CAB). Vonoprazan has been studied and used successfully in Japan for H pylori eradication therapy, GERD, gastric and duodenal ulcers with favorable safety profile. However, to the author's knowledge, no study yet exists comparing vonoprazan to a proton pump inhibitor in the treatment of GERD outside Japan. This study aims to determine whether vonoprazan is superior to omeprazole in relieving symptoms in treatment-naïve adult patients with GERD.

Condition or disease Intervention/treatment Phase
GERD Gastro Esophageal Reflux Drug: Vonoprazan Drug: Omeprazole Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic, Randomized, Single Blind Study
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Randomized, Single Blind Study. Only primary investigators are blinded. the primary investigator also are the outcome assessors
Primary Purpose: Treatment
Official Title: Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features in a Primary Care Setting: A Pragmatic, Randomized, Single Blind Study
Actual Study Start Date : May 26, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Vonoprazan
Patients will be randomized to receiving vonoprazan, which will be taken 30 minutes before the first meal of the day for 14 days
Drug: Vonoprazan
Patients will be randomized to receiving vonoprazan 20mg tablet or omeprazole 40mg capsule, either of which will be taken 30 minutes before the first meal of the day for 14 days
Other Name: Investigational Arm

Active Comparator: Omeprazole
Patients will be randomized to receiving omeprazole, which will be taken 30 minutes before the first meal of the day for 14 days
Drug: Omeprazole
Patients will be randomized to receving vonoprazan 20mg tablet or omeprazole 40mg capsule, either of which will be taken 30 minutes before the first meal of the day for 14 days
Other Name: Control Arm




Primary Outcome Measures :
  1. Proportion of asymptomatic patients at Day 3 [ Time Frame: day 3 of therapy ]
    Asymptomatic patients is defined as a patient being free of symptoms of heartburn or acid regurgitation according to FSSG questionnaire (score <8) Expressed in percentage

  2. Proportion of asymptomatic patients at Day 7 [ Time Frame: day 7 of therapy ]
    Asymptomatic patients is defined as a patient being free of symptoms of heartburn or acid regurgitation according to FSSG questionnaire (score <8) Expressed in percentage

  3. Proportion of asymptomatic patients at Day 14 [ Time Frame: day 14 of therapy ]
    Asymptomatic patients is defined as a patient being free of symptoms of heartburn or acid regurgitation according to FSSG questionnaire (score <8) Expressed in percentage


Secondary Outcome Measures :
  1. Proportion of partial responders at Day 3 [ Time Frame: day 3 of therapy ]
    Partial responder are patients who still have GERD symptoms, but with partial improvement on reevaluation using the FSSG questionnaire; patients with at least 50% reduction from the baseline FSSG score Expressed in percentage

  2. Proportion of partial responders at Day 7 [ Time Frame: day 7 of therapy ]
    Partial responder are patients who still have GERD symptoms, but with partial improvement on reevaluation using the FSSG questionnaire; patients with at least 50% reduction from the baseline FSSG score Expressed in percentage

  3. Proportion of partial responders at Day 14 [ Time Frame: day 14 of therapy ]
    Partial responder are patients who still have GERD symptoms, but with partial improvement on reevaluation using the FSSG questionnaire; patients with at least 50% reduction from the baseline FSSG score Expressed in percentage

  4. Proportion of nonresponders at Day 14 [ Time Frame: day 14 of therapy ]
    Nonresponders are patients who reported no significant improvement in symptoms with treatment; patients with less than 50% reduction from the baseline FSSG score Expressed in percentage

  5. Percent change in the symptom score from baseline (Vonoprazan Group) - Day 3 [ Time Frame: day 3 of therapy ]
    Difference in the symptom score from baseline using the FSSG questionnaire at each time point within Vonoprazan and omeprazole group; expressed in percentage

  6. Percent change in the symptom score from baseline (Vonoprazan Group) - Day 7 [ Time Frame: day 7 of therapy ]
    Difference in the symptom score from baseline using the FSSG questionnaire at each time point within Vonoprazan and omeprazole group; expressed in percentage

  7. Percent change in the symptom score from baseline (Vonoprazan Group) - Day 14 [ Time Frame: day 14 of therapy ]
    Difference in the symptom score from baseline using the FSSG questionnaire at each time point within Vonoprazan and omeprazole group; expressed in percentage

  8. Difference in percent change in the symptom score (between groups) [ Time Frame: day 3, 7, and 14 of therapy ]
    Difference in the percent change of the FSSG score between groups will be analyzed using independent T test or Mann-Whitney U test between vonoprazan and omeprazole groups at one point in time

  9. Number of Patients with Adverse Effects [ Time Frame: Day 14 of therapy ]
    Safety and frequency of adverse effects experienced by patients (nasopharyngitis, diarrhea, constipation, upper respiratory tract infection, gastroenteritis, eczema/allergy, hypergastrinemia)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All Adult patients with clinically diagnosed with Gastroesophageal Reflux Disease (GERD) without alarm features (heartburn and acid regurgitation)
  • Age more than 18 years at the time of written consent
  • Those who provide written consent with their own free will
  • Both treatment naïve and treatment experienced patients will be included. Treatment experienced patients should not be taking any proton pump inhibitors for 2 weeks to allow for washout period.

Exclusion Criteria:

  • Patients that have alarm features as defined by the Philippines Guidelines for GERD (dysphagia, odynophagia, weight loss, anemia, hematemesis, family history of esophageal adenocarcinoma, nocturnal choking, abdominal mass, recurrent/frequent vomiting, chest pain)
  • Patients with atypical GERD symptoms (cough, laryngitis, chest pain, etc.)
  • Patients already taking proton pump inhibitors for the past 2 weeks
  • Patients who scored less than 8 on the FSSG questionnaire
  • Patients who have undergone gastroesophageal surgery
  • Patients who are poorly compliant to medications
  • allergy to PPI or vonoprazan
  • With serious comorbidities, such as but not limited to: heart failure, renal failure, malignancy or hepatic failure
  • Pregnant, breastfeeding or possibly pregnant
  • Patients that would not provide consent
  • Patients who are unable to complete the FSSG Questionnaire independently
  • Patients who are unable to follow up at designated periods
  • Patients taking rilpivirine or atazanavir.
  • Patients with elevated baseline liver function tests (more than twice the upper limit of normal)

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): NCT04028466


Contacts
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Contact: Nicodemus L Ong, MD +639176791018 nico.ongmd@yahoo.com
Contact: Sherrie Isabel Q De Ocampo, MD 09338555954 sherrieq@hotmail.com

Locations
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Philippines
St. Luke's Medical Center Recruiting
Quezon City, National Capital Region, Philippines, 1112
Contact: Nicodemus L Ong, MD    9176791018    nico.ongmd@yahoo.com   
Contact: Sherrie Isabel Q de Ocampo, MD    9338555954    sherrieq@hotmail.com   
Principal Investigator: NIcodemus L Ong, MD         
Principal Investigator: Sherrie Isabel Q de Ocampo, MD         
Sponsors and Collaborators
St. Luke's Medical Center, Philippines
Investigators
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Principal Investigator: Nicodemus L Ong, MD Institute of Digestive and Liver Diseases, St. Luke's Medical Center, Quezon City
Principal Investigator: Sherrie Isabel Q De Ocampo, MD Institute of Digestive and Liver Diseases, St. Luke's Medical Center, Quezon City

Publications of Results:

Other Publications:

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Responsible Party: Nicodemus Ong, Fellow and Principal Investigator, Institute of Digestlve and Liver Diseases, St. Luke's Medical Center, Philippines
ClinicalTrials.gov Identifier: NCT04028466     History of Changes
Other Study ID Numbers: RP 19-007
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Approval from the Institutional review board should be secured before IPD will be made available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nicodemus Ong, St. Luke's Medical Center, Philippines:
GERD
gastro esophageal reflux
proton pump inhibitor
Potassium-Competitive Acid Blocker
H(+)-K(+)-Exchanging ATPase
Randomized Controlled Trial

Additional relevant MeSH terms:
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Omeprazole
Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action