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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation (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 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 Summary:

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.

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.


Sponsor: Takeda

Current Primary Outcome: Changes from Start of Administration (Week 0) in PSQI global score at End of Study [ Time Frame: From Week 0 to End of study (up to Week 8) ]

PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes from Start of Administration (Week 0) in PSQI global score at Week 4 [ Time Frame: From Week 0 to Week 4 ]
  • Percentage of participants with PSQI global score <6.0 at Week 4, and End of Study [ Time Frame: Week 4, and End of study (up to Week 8) ]
  • Changes from Start of Administration (Week 0) in 6 component scores of PSQI (Sleep quality, Sleep latency, Sleep duration, Habitual sleep efficiency, Sleep disturbances, Daytime dysfunction) at Week 4, and End of study [ Time Frame: From Week 0 to Week 4, and to End of study (up to Week 8) ]
  • Changes from Start of Administration (Week 0) in number of nocturnal awakenings at Week 4, and End of Study [ Time Frame: From Week 0 to Week 4, and to End of study (up to Week 8) ]
    Number of nocturnal awakenings was assessed by one of 13 questions about nocturnal awakenings.
  • Changes from Start of Administration (Week 0) in actigraph-measured sleep efficiency at Week 4, and End of Study [ Time Frame: From Week 0 to Week 4, and to End of study (up to Week 8) ]
    Actigraph is a small device usually that records the activity level of the body by sensing physical movement and that is used especially to measure the amount and quality of sleep. Mean value from the past 7 days at each time point will be used for calculation.
  • Changes from Start of Administration (Week 0) in actigraph-measured sleep latency at Week 4, and End of Study [ Time Frame: From Week 0 to Week 4, and to End of study (up to Week 8) ]
    Mean value from the past 7 days at each time point will be used for calculation.
  • Changes from Start of Administration (Week 0) in actigraph-measured number of nocturnal awakenings at Week 4, and End of Study [ Time Frame: From Week 0 to Week 4, and to End of study (up to Week 8) ]
    Mean value from the past 7 days at each time point will be used for calculation.
  • Number of participants reporting one or more adverse events [ Time Frame: Up to End of Study (up to Week 8) ]


Original Secondary Outcome: Same as current

Information By: Takeda

Dates:
Date Received: April 12, 2017
Date Started: April 21, 2017
Date Completion: December 31, 2017
Last Updated: April 24, 2017
Last Verified: April 2017