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Efficacy and Safety of Valagliflozin Proglumetac Capsules in the Treatment of Reflux Esophagitis: A Multicenter, Prospective, Real-World Study

Efficacy and Safety of Valagliflozin Proglumetac Capsules in the Treatment of Reflux Esophagitis: A Multicenter, Prospective, Real-World Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123809
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Reflux Esophagitis

Interventions

Non-P-CAB treatment group:None
Linalaxate treatment group:None

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years and <=75 years, with no gender restriction. 2.Patients diagnosed with reflux esophagitis of Los Angeles (LA) Grade A to D by endoscopy. 3.Participants have been informed of all relevant requirements of the study, are willing to participate, and have provided written informed consent.

Exclusion criteria

Exclusion criteria: 1.Hypersensitivity to valagliflozin proglumetac or any of its excipients; 2.Current use of atazanavir, nelfinavir, or rilpivirine (to avoid drug-drug interactions); 3.Pregnant or lactating female; or female of childbearing potential with a positive blood/urine pregnancy test during the screening period; or female of childbearing potential unwilling to use effective contraceptive measures during the study; 4.Subjects judged by the investigator to have severe disorders of the central nervous system, respiratory system, urinary system, endocrine system, or hematological system, which may confound study results, compromise subject safety, or constitute other conditions inappropriate for trial participation. 5.Patients with severe hepatic and renal insufficiency, defined as: liver cirrhosis of Child-Pugh Class B/C, markedly abnormal liver function laboratory parameters (e.g., ALT/AST > 3 × upper limit of normal, INR > 1.5), or end-stage renal disease with an estimated glomerular filtration rate < 30 mL/min/1.73 m^2.

Design outcomes

Primary

MeasureTime frame
At the end of the 8-week treatment period, the proportion of patients with endoscopically confirmed esophageal mucosal healing was compared between the two groups.;

Secondary

MeasureTime frame
Improvement of symptoms;Safety;

Countries

China

Contacts

Public ContactTanzhou Chen

The First Affiliated Hospital of Wenzhou Medical University

cctzz@163.com+86 577 86689192

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026