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Enrolling by Invitation

NCT Number: NCT07437768

Vonoprazan Test for PPI Refractory GERD

Among patients suffering from gastroesophageal reflux disease (GERD) symptoms, esophageal pH monitoring and the assessment of symptom-reflux correlation can identify two distinct subgroups characterized by normal acid exposure: functional heartburn and reflux hypersensitivity. Given the absence of abnormal acid exposure in these groups, conventional antacid therapies often yield unsatisfactory clinical outcomes.

Therefore, in cases of PPI-refractory GERD, it is hypothesized that patients with underlying abnormal acid reflux will respond to Vonoprazan, a more potent potassium-competitive acid blocker (P-CAB). Conversely, those whose symptoms are unrelated to acid reflux are expected to show poor response. For future refractory patients without definitive endoscopic evidence of GERD (such as Los Angeles Grade B, C, or D esophagitis, peptic stricture, or histologically confirmed Barrett's esophagus), a Vonoprazan therapeutic trial could potentially bypass the need for invasive high-resolution manometry (HRM) and 24-hour pH-impedance monitoring. Evaluating the efficacy of Vonoprazan may offer diagnostic insights while minimizing patient discomfort and reducing overall healthcare expenditures.

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Key information

Conditions

Refractory GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases NERD PCAB

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fu Jen Catholic University Hospital

New Taipei City, Taiwan, 24352

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged between 20 and 75 years.
  • Outpatients at Fu Jen Catholic University Hospital who had undergone esophagogastroduodenoscopy (EGD) within the past year.
  • Presence of persistent GERD symptoms, including acid regurgitation, heartburn, chest pain, globus sensation, or chronic cough. PPI-refractory GERD, defined as persistent symptoms despite receiving at least 8 weeks of standard-dose proton pump inhibitor (PPI) therapy (GerdQ > = 8).
  • Scheduled to undergo high-resolution manometry (HRM) and 24-hour esophageal pH-impedance monitoring.
  • Patients with a history of any grade of erosive esophagitis confirmed by gastroscopy.

Exclusion criteria

  • major esophageal motility disorders
  • history of upper gastrointestinal surgery
  • malignant tumors
  • liver cirrhosis.
  • esophageal strictures
  • esophageal varices
  • gastrointestinal obstruction
  • significant acute GI bleeding
  • LA Grade B, C, or D erosive esophagitis,
  • esophageal peptic stricture
  • biopsy-proven Barrett's esophagus
  • severe renal impairment (CrCl < 30 mL/min)
  • long-term dialysis, pregnancy
  • hypersensitivity to vonoprazan or its excipients.
  • patients currently taking atazanavir sulfate or rilpivirine hydrochloride,
  • dependent on tube feeding
  • unable to cooperate due to impaired consciousness

Treatment and study plan

Patients received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®)

Drug

Participants undergoing HRM and 24-hour pH-impedance monitoring were enrolled after providing informed consent. Baseline GERD-related questionnaires were administered on the day of the procedure. Patients then received a 4-week treatment of vonoprazan 20 mg once daily (VOCINTI®). After four weeks, patients returned for a follow-up visit to review their diagnostic reports and complete a second set of questionnaires. Final treatment strategies were adjusted according to the test findings.

Primary outcomes

  1. All participants were evaluated using the following validated symptom questionnaires: The GERD Questionnaire

    Time frame: 4 weeks

    The GERD Questionnaire (GerdQ) includes 4 positive predictors (heartburn, regurgitation, reflux-related sleep disturbance, and use of over-the-counter medications) and 2 negative predictors (epigastric pain and nausea) for GERD.

    The GerdQ score ranges from 0 to 18. A higher score indicates a higher probability of GERD and a greater symptom burden. A cutoff score of 8 or higher is generally used to identify patients with a high likelihood of having GERD.

Secondary outcomes

  1. The Reflux Symptom Index (RSI)

    Time frame: 4 weeks

    The Reflux Symptom Index (RSI) consists of 9 items (e.g., hoarseness, frequent throat clearing, and globus sensation), each rated on a scale from 0 (no problem) to 5 (severe) based on the severity of symptoms.

    Minimum score: 0

    Maximum score: 45

  2. The 5-item Brief Symptom Rating Scale (BSRS-5)

    Time frame: 4 weeks

    The BSRS-5 score ranges from 0 to 20. A higher score indicates greater psychological distress.

    The 5-item Brief Symptom Rating Scale (BSRS-5) was used to screen for common psychiatric conditions, such as anxiety and depression; a score ≥ 6 indicates potential psychological morbidity.

  3. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 4 weeks

    The Pittsburgh Sleep Quality Index (PSQI) is a 7-item self-rated questionnaire used to assess sleep quality over the preceding month; a global PSQI score > 5 indicates poor sleep quality or sleep disturbance.

    The PSQI global score ranges from 0 to 21. A higher score indicates poorer sleep quality.

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University Hospital

Other

Registry information

Official study title

Vonoprazan Test for Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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