Reflux EsophagitisPhase 4VISTAEXENCT03116841

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

A Phase 4 study testing Vonoprazan in people with Reflux Esophagitis, run by Takeda at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Reflux Esophagitis
What is being tested?: Vonoprazan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 6 sitesJapan
Study dates: 2 Aug 2017to 20 Dec 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Participants who have heartburn and/or regurgitation.
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
Participants whose heartburn and/or regurgitation at the time of informed consent were alleviated from initial treatment.

Show all 11Show fewer

Participants with PSQI global score > = 6.0
Participants who, in the opinion of the investigator, are capable of understanding the content of the study and complying with the protocol requirements.
Participants who can sign and date an informed consent form and information sheet prior to the initiation of the study procedures.
Male or female participants aged 20 years or older at the time of informed consent.
Therapeutic category: Ambulatory

Who cannot join

Participants with Zollinger-Ellison syndrome.
Participants with diseases that affect sleep (chronic obstructive pulmonary disease, bronchitis asthma, sleep apnea syndrome, mental disorder, etc.)
Nightshift workers.
Participants who have a plan to travel beyond three time zones during the study.
Participants with a history of, concurrent, or suspicious functional dyspepsia or functional heartburn based on Rome IV criteria.
Participants with history of surgery or treatment affecting gastroesophageal reflux (fundoplication or dilation for esophageal stenosis [except for Schatzki's ring], etc.).

Show all 20Show fewer

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.
Participants with a history of gastrectomy, gastrointestinal resection, or vagotomy.
Participants who took antidepressant agents or anti-anxiety agents within 8 weeks before the time of informed consent.
Participants who took H2 receptor antagonist within 8 weeks before the time of informed consent.
Participants planning to take prohibited concomitant medications during the study period.
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
Participants with a malignant tumor.
Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant.
Participants who have serious renal diseases.
Participants with the conditions listed under administration contraindication in the vonoprazan package insert.
Participants participating in other clinical studies.
Participants who have been determined as inappropriate participants by the investigator.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Japan6 sites

Tokatsu Tsujinaka Hospital
Abiko, Chiba
Kashiwara Municipal Hospital
Kashihara, Osaka
Aoyama Clinic
Kobe, Hyōgo
Amada Clinic
Kōriyama, Fukushima
Masuyama Clinic
Ōtawara, Tochigi
Saino Clinic
Tokorozawa, Saitama

Other trials in Japan

About this study

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

Read the 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
Being tested: Vonoprazan
Medical subject headings: Esophagitis, Peptic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VonoprazanDrug
Vonoprazan 20 mg

Study groups in NCT03116841
Study group	Role	What they receive
Vonoprazan 20 mg	Experimental	Vonoprazan 20 mg orally administered once daily Receives: Drug: Vonoprazan

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes From Start of Administration (Week 0) in Pittsburgh Sleep Quality Index (PSQI) Global Score at End of Study
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).
Measured: Week 0 to End of study (up to Week 8)

Secondary outcomes (13)

Changes From Start of Administration (Week 0) in PSQI Global Score at 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).
Measured: From Week 0 to Week 4
Percentage of Participants With PSQI Global Score <6.0 at Week 4 and End of Study
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.
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: Week 4 and End of study (up to Week 8)
Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)
Measured: Up to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 201720 Dec 2017

First posted17 Apr 2017
Study start2 Aug 2017
Primary completion20 Dec 2017
Study completion20 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Reflux EsophagitisStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03116841
Sponsor's protocol ID: Vonoprazan-4006
Other IDs: U1111-1192-9760, JapicCTI-173538
Acronym: VISTAEXE
Status last verified: Dec 2018
First submitted: 12 Apr 2017
Last updated: 29 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Not yet recruitingPhase 4
PPI Dosing Per CYP2C19 Genotype
Gastroesophageal Reflux Disease With Esophagitis
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
Gastroesophageal Reflux Disease, Hiatal Hernia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn

All Reflux Esophagitis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation (VISTAEXE)
ClinicalTrials.gov ID: NCT03116841
Acronym / sponsor ID: VISTAEXE / Vonoprazan-4006
Conditions: Reflux Esophagitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 3 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 2 Aug 2017 (actual)
Primary completion: 20 Dec 2017 (actual)
Study completion: 20 Dec 2017 (actual)
First posted: 17 Apr 2017 (actual)
Results: Posted 29 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Planned number of participants is 25. The study period is 9 weeks. The number of visits is 6visits.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vonoprazan 20 mg	Experimental	Drug: VonoprazanVonoprazan 20 mg orally administered once daily

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.
Participants who have heartburn and/or regurgitation.
Participants with reflux esophagitis related sleep disturbance, fulfilling at least one of following in a week before the baseline/start of administration.
Participants whose heartburn and/or regurgitation at the time of informed consent were alleviated from initial treatment.
Participants with PSQI global score > = 6.0

Key exclusion criteria (20 listed)

Participants with Zollinger-Ellison syndrome.
Participants with diseases that affect sleep (chronic obstructive pulmonary disease, bronchitis asthma, sleep apnea syndrome, mental disorder, etc.)
Nightshift workers.
Participants who have a plan to travel beyond three time zones during the study.
Participants with a history of, concurrent, or suspicious functional dyspepsia or functional heartburn based on Rome IV criteria.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VonoprazanVonoprazan 20 mg	Drug	Vonoprazan 20 mg

Primary outcome

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).

13 secondary outcomes

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 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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)
Time frame: Up to Week 8

Results and safety

Results posted to the registry on 29 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vonoprazan 20mg	3	3

Primary outcome: 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). Number. Unit: Scores on a Scale

Measure	Vonoprazan 20mg n = 3
Participant A	-2
Participant B	1
Participant C	-6

Population analysed: Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 8. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vonoprazan 20mg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Related trials for Reflux Esophagitis

Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Not yet recruitingPhase 4
PPI Dosing Per CYP2C19 Genotype
Gastroesophageal Reflux Disease With Esophagitis
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
Gastroesophageal Reflux Disease, Hiatal Hernia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vonoprazan in people with Reflux Esophagitis, run by Takeda at 6 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03116841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.