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The Diagnostic Value and Influencing Factors of Tegoprazan Test for Gastro-esophageal Reflux Disease

The Diagnostic Value and Influencing Factors of Tegoprazan Test for Gastro-esophageal Reflux Disease - Diagnostic Value of Tegoprazan Test for GRED

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200065994
Enrollment
Unknown
Registered
2022-11-21
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Gastro-sophageal Reflux Disease

Interventions

Sponsors

The Third People's Hospital of Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with aged 18-75 years; 2. Patients with typical reflux disease symptoms: heartburn and/or reflux, symptoms lasting more than 3 months, at least twice a week; 3. Patients who voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients contraindicated by endoscopy, esophageal pH test and tegoprazan treatment; 2. Patients with warning symptoms, such as unexplained weight loss in the past 3 months, hematemesis, melena or blood in the stool in the past year, progressive dysphagia, anemia or any other symptoms suggestive of suspected malignancy; 3. Patients with any grade of esophageal intraepithelial neoplasia or esophageal cancer, esophageal varices or ulcers, eosinophilic esophagitis or other organic lesions, or hiatal hernia >= 3 cm; 4. Patients with esophageal obstructive lesions (including achalasia and mechanical obstruction) and severe esophageal motility disorders (including distal esophageal spasm, non-contractile esophagus, hypercontractile esophagus); 5. Patients with upper gastrointestinal surgery, such as subtotal gastrectomy, anti-reflux surgery or endoscopic submucosal dissection; 6. Subjects who had taken taken acid suppressors or prokinetic drugs (except antacids) within 7 days before enrollment, and those who refused to discontinue the drugs during the study; 7. Patients taking aspirin and NSAIDs, including COX-2 inhibitors; 8. Patients of lactation or pregnancy; 9. Patients with a history of other serious diseases, such as severe cardiopulmonary disease, renal failure or liver failure.

Design outcomes

Primary

MeasureTime frame
the sensitivity of the Tegoprazan-test;the specificity of the Tegoprazan-test;

Secondary

MeasureTime frame
the sensitivity of the Tegoprazan-test combined with gastro-esophageal reflux disease questionnaire;the sensitivity of the Tegoprazan-test combined with gastro-esophageal reflux disease questionnaire;

Countries

China

Contacts

Public ContactWang Qiong

The Third People's Hospital of Chengdu

462602173@qq.com+86 18981948153

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026