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

December 20, 2018 updated by: Takeda

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Chiba
      • Abiko, Chiba, Japan
        • Tokatsu Tsujinaka Hospital
    • Fukushima
      • Koriyama, Fukushima, Japan
        • Amada Clinic
    • Hyogo
      • Kobe, Hyogo, Japan
        • Aoyama Clinic
    • Osaka
      • Kashiwara, Osaka, Japan
        • Kashiwara Municipal Hospital
    • Saitama
      • Tokorozawa, Saitama, Japan
        • Saino Clinic
    • Tochigi
      • Otawara, Tochigi, Japan
        • Masuyama Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participants who completed the initial treatment with PPIs (esomeprazole, omeprazole, rabeprazole, or lansoprazole) and have received high dose PPIs (esomeprazole 20 mg, omeprazole 20 mg, rabeprazole 10 mg, or lansoprazole 30 mg) for more than 8 weeks at the time of informed consent as maintenance treatment for LA Classification Grades A to D reflux esophagitis.
  2. Participants who have heartburn and/or regurgitation.
  3. Participants with reflux esophagitis related sleep disturbance, fulfilling at least one of following in a week before the baseline/start of administration.

    • Difficulty in falling asleep for > = 3 nights
    • Nocturnal awaking or early morning awaking for > = 3 nights
  4. Participants whose heartburn and/or regurgitation at the time of informed consent were alleviated from initial treatment.
  5. Participants with PSQI global score > = 6.0
  6. Participants who, in the opinion of the investigator, are capable of understanding the content of the study and complying with the protocol requirements.
  7. Participants who can sign and date an informed consent form and information sheet prior to the initiation of the study procedures.
  8. Male or female participants aged 20 years or older at the time of informed consent.
  9. Therapeutic category: Ambulatory

Exclusion Criteria:

  1. Participants with Zollinger-Ellison syndrome.
  2. Participants with diseases that affect sleep (chronic obstructive pulmonary disease, bronchitis asthma, sleep apnea syndrome, mental disorder, etc.)
  3. Nightshift workers.
  4. Participants who have a plan to travel beyond three time zones during the study.
  5. Participants with a history of, concurrent, or suspicious functional dyspepsia or functional heartburn based on Rome IV criteria.
  6. Participants with history of surgery or treatment affecting gastroesophageal reflux (fundoplication or dilation for esophageal stenosis [except for Schatzki's ring], etc.).
  7. Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
  8. Participants with a history of gastrectomy, gastrointestinal resection, or vagotomy.
  9. Participants who took antidepressant agents or anti-anxiety agents within 8 weeks before the time of informed consent.
  10. Participants who took H2 receptor antagonist within 8 weeks before the time of informed consent.
  11. Participants planning to take prohibited concomitant medications during the study period.
  12. Participants who have any of the following abnormal clinical laboratory test values at the screening (VISIT 1):

    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN)
    • Bilirubin (Total bilirubin) > ULN
  13. Participants with a malignant tumor.
  14. Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant.
  15. Participants who have serious renal diseases.
  16. Participants with the conditions listed under administration contraindication in the vonoprazan package insert.
  17. Participants participating in other clinical studies.
  18. Participants who have been determined as inappropriate participants by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vonoprazan 20 mg
Vonoprazan 20 mg orally administered once daily
Vonoprazan 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes From Start of Administration (Week 0) in Pittsburgh Sleep Quality Index (PSQI) Global Score at End of Study
Time Frame: 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. Reported data were individual scores for each participant (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Week 0 to End of study (up to Week 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes From Start of Administration (Week 0) in PSQI Global Score at Week 4
Time Frame: From Week 0 to Week 4
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. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
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)
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.
Week 4 and End of study (up to Week 8)
Changes From Start of Administration (Week 0) in C1: Sleep Quality of PSQI Global Score at Week 4 and End of Study
Time Frame: Week 0, Week 4 and 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. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Week 0, Week 4 and End of study (up to Week 8)
Changes From Start of Administration (Week 0) in C2: Sleep Latency of PSQI Global Score at Week 4 and End of Study
Time Frame: Week 0, Week 4 and 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. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Week 0, Week 4 and End of study (up to Week 8)
Changes From Start of Administration (Week 0) in C3: Sleep Duration of PSQI Global Score at Week 4 and End of Study
Time Frame: Week 0, Week 4 and 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. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Week 0, Week 4 and End of study (up to Week 8)
Changes From Start of Administration (Week 0) in C4: Sleep Efficiency of PSQI Global Score at Week 4 and End of Study
Time Frame: Week 0, Week 4 and 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. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Week 0, Week 4 and End of study (up to Week 8)
Changes From Start of Administration (Week 0) in C5: Sleep Disturbance of PSQI Global Score at Week 4 and End of Study
Time Frame: Week 0, Week 4 and 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. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Week 0, Week 4 and End of study (up to Week 8)
Changes From Start of Administration (Week 0) in C7: Daytime Dysfunction of PSQI Global Score at Week 4 and End of Study
Time Frame: Week 0, Week 4 and 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. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Week 0, Week 4 and End of study (up to Week 8)
Number of Nocturnal Awakenings Assessed by a Question at Week 4, and End of Study
Time Frame: Week 4 and End of study (up to Week 8)
Number of nocturnal awakenings was assessed by a question about nocturnal awakenings, "How Many Times Wake Up?" which was asked to each participants by investigator. Reported data were individual times for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Week 4 and End of study (up to Week 8)
Percent Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Efficiency at Week 4, and End of Study
Time Frame: Week 4 and 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 was used for calculation. Reported data were individual values for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Week 4 and End of study (up to Week 8)
Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Latency at Week 4, and End of Study
Time Frame: Week 4 and 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. Reported data were individual values for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Week 4 and End of study (up to Week 8)
Changes From Start of Administration (Week 0) in Actigraph-Measured Number of Nocturnal Awakenings at Week 4, and End of Study
Time Frame: Week 4 and 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 was used for calculation. Reported data were individual times for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).
Week 4 and End of study (up to Week 8)
Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)
Time Frame: Up to Week 8
Up to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2017

Primary Completion (Actual)

December 20, 2017

Study Completion (Actual)

December 20, 2017

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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