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The diagnostic value and influencing factors of Tigorazan test in gastroesophageal reflux disease: a multicenter, prospective, single-blind clinical study

The diagnostic value and influencing factors of Tigorazan test in gastroesophageal reflux disease: a multicenter, prospective, single-blind clinical study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093370
Enrollment
Unknown
Registered
2024-12-03
Start date
2024-07-19
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Gastroesophageal 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+86 189 8194 8153

Outcome results

None listed

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