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The Diagnostic Value of Short-Course Vonoprazan Test for the Diagnosis of Gastro-Oesophageal Reflux Disease

The Diagnostic Value of Short-Course Vonoprazan Test for the Diagnosis of Gastro-Oesophageal Reflux Disease

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039629
Enrollment
Unknown
Registered
2020-11-03
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Interventions

Test
Gold Standard:Endoscopy and esophageal pH monitoring
Index test:Short-course&#32
Vonoprazan&#32

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-70 years; 2. Patients with typical symptoms of gastroesophageal reflux disease: heartburn and / or reflux, symptoms lasting more than 3 months, at least twice a week; 3. The subjects who sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients with gastrointestinal ulcer or malignant tumor found under endoscopy; 2. Patients with digestive tract operation history; 3. Patients with esophageal motility disorders, such as achalasia, etc; 4. Patients with a history of other serious diseases, such as severe cardiopulmonary disease, diabetes or rheumatic diseases, renal failure or liver failure; 5. Subjects who had taken anti ulcer and anti reflux drugs within 7 days before enrollment (except for anti acid drugs or alginate), and those who refused to stop using such drugs during the study period; 6. Patients taking NSAIDs; 7. Subjects who used any experimental drugs within 16 weeks before enrollment or during the study period; 8. Patients allergic to vonora; 9. Subjects of lactation or pregnancy; 10. The subjects of alcohol or drug abuse, and the poor compliance caused by any reason.

Design outcomes

Primary

MeasureTime frame
The sensitivity of the 4-week P-CAB test;The specificity of the 4-week P-CAB test for the diagnosis of GERD;

Countries

China

Contacts

Public ContactMinhu Chen

The First Affiliated Hospital of Sun Yat-Sen University

chenminhu@vip.163.com+86 20-87332916

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026