NCT03116841

Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation

Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation (VISTAEXE)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to exploratorily evaluate the effect of vonoprazan 20 mg on sleep disturbance of patients with reflux esophagitis, who have heartburn and/or regurgitation and ≥ 6.0 in the Pittsburgh Sleep Quality Index (PSQI) global score despite the maintenance treatment with PPI other than vonoprazan.

Detailed description

The purpose of this study is to evaluate the effect of vonoprazan on sleep disturbance in the participants under maintenance treatment for reflux esophagitis with proton pump inhibitor (PPI) other than vonoprazan after initial treatment. Participants who have been diagnosed as reflux esophagitis based on Los Angeles (LA) Classification Grades A to D, undergoing maintenance treatment with PPI other than vonoprazan after initial treatment, and with Pittsburgh Sleep Quality Index (PSQI) global score \>= 6.0 at enrolment (VISIT 1) will be eligible for study entry and will be administered vonoprazan 20 mg once daily for 8 weeks. Planned number of participants is 25. The study period is 9 weeks. The number of visits is 6visits.

Conditions

• Reflux Esophagitis

Interventions

Type	Name	Description
DRUG	Vonoprazan	Vonoprazan 20 mg

Timeline

• Start date: 2017-08-02
• Primary completion: 2017-12-20
• Completion: 2017-12-20
• First posted: 2017-04-17
• Last updated: 2019-03-29
• Results posted: 2019-03-29

Locations

6 sites across 1 country: Japan