Ignite Creation Date:
2024-05-06 @ 9:55 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03116841
Status:
COMPLETED
Last Update Posted:
2019-03-29
First Post:
2017-04-12
Brief Title:
Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation VISTAEXE
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VISTAEXE
Brief 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 andor regurgitation and 60 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 60 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
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 60 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1192-9760 | REGISTRY | None | None |
| JapicCTI-173538 | REGISTRY | Japic-CTI | None |