UMIN ID: UMIN000055462
Registered date:11/09/2024
Risk factors for recurrence after initial treatment with vonoprazan 20 mg/day in patients with mild reflux esophagitis: A prospective multicenter study
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Gastroesophageal reflux disease (mild) |
| Date of first enrollment | 2024/09/11 |
| Target sample size | 150 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Factors associated with symptom recurrence 2 weeks after discontinuing vonoprazan |
|---|---|
| Secondary Outcome | Factors associated with symptom recurrence 4 weeks after discontinuation of vonoprazan Factors associated with symptom recurrence 2 or 4 weeks after discontinuation of vonoprazan |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 90years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients with any of the following conditions will be excluded. 1) Severe reflux esophagitis 2) Non-erosive reflux esophagitis 3) Gastroduodenal ulcer 4) Post-surgery of the upper gastrointestinal tract 5) Use of acid secretion inhibitors (H2 blockers, PPIs, P-CABs) within the past 3 months 6) Use of medications that affect reflux esophagitis or heartburn (analgesics such as Rikkunshito, mosapride citrate, acotiamide, antipsychotics, and NSAIDs) 7) Severe systemic disease 8) Psychiatric disease |
Related Information
| Primary Sponsor | Akita University Graduate School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Akita University Graduate School of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kenta Watanabe |
| Address | 1-1-1 Hondo, Akita, Japan Japan 010-8543 |
| Telephone | 018-884-6104 |
| nabeken@med.akita-u.ac.jp | |
| Affiliation | Akita University Graduate School of Medicine Department of Gastroenterology |
| scientific contact | |
| Name | Kenta Watanabe |
| Address | 1-1-1 Hondo, Akita, Japan Japan |
| Telephone | 018-884-6104 |
| nabeken@med.akita-u.ac.jp | |
| Affiliation | Akita University Graduate School of Medicine Department of Gastroenterology |