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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1192-9760 | Registry Identifier | WHO | |
| JapicCTI-173538 | Registry Identifier | Japic-CTI |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonoprazan 20 mg | Experimental | Vonoprazan 20 mg orally administered once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Vonoprazan 20 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 0 to End of study (up to Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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
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
Exclusion Criteria:
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.).
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):
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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokatsu Tsujinaka Hospital | Abiko | Chiba | Japan | |||
| Amada Clinic |
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.
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Participants with a historical diagnosis of reflux esophagitis, undergoing maintenance treatment with a proton pump inhibitors (PPI) after initial treatment, and with Pittsburgh Sleep Quality Index (PSQI) global score ≥ 6.0 at the start of administration (VISIT 2) were enrolled and was administered vonoprazan 20 mg once daily for 8 weeks.
Participants took part in the study in Japan, from 02 August 2017 to 20 December 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vonoprazan 20mg | Vonoprazan 20 mg, orally, once daily, for up to 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vonoprazan 20mg | Vonoprazan 20 mg, orally, once daily, for up to 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Number | Scores on a Scale | Week 0 to End of study (up to Week 8) |
|
Up to Week 8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vonoprazan 20mg | Vonoprazan 20 mg, orally, once daily, for up to 8 weeks. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral upper respiratory tract | Infections and infestations | MedDRA Ver. 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 28, 2017 | Dec 20, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2018 | Dec 20, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
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| 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. | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | Week 4 and End of study (up to Week 8) |
| Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE) | Up to Week 8 |
| Kōriyama |
| Fukushima |
| Japan |
| Aoyama Clinic | Kobe | Hyōgo | Japan |
| Kashiwara Municipal Hospital | Kashihara | Osaka | Japan |
| Saino Clinic | Tokorozawa | Saitama | Japan |
| Masuyama Clinic | Ōtawara | Tochigi | Japan |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.
|
|
| Secondary | 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). | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Number | Scores on a Scale | From Week 0 to Week 4 |
|
|
|
| Secondary | 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. | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Number | Percentage of Participants | Week 4 and End of study (up to Week 8) |
|
|
|
| Secondary | 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). | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Number | Scores on a Scale | Week 0, Week 4 and End of study (up to Week 8) |
|
|
|
| Secondary | 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). | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Number | Scores on a Scale | Week 0, Week 4 and End of study (up to Week 8) |
|
|
|
| Secondary | 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). | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Number | Scores on a Scale | Week 0, Week 4 and End of study (up to Week 8) |
|
|
|
| Secondary | 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). | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Number | Scores on a Scale | Week 0, Week 4 and End of study (up to Week 8) |
|
|
|
| Secondary | 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). | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Number | Scores on a Scale | Week 0, Week 4 and End of study (up to Week 8) |
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|
|
| Secondary | 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). | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Number | Scores on a Scale | Week 0, Week 4 and End of study (up to Week 8) |
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| Secondary | 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). | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Number | Nocturnal awakenings | Week 4 and End of study (up to Week 8) |
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| Secondary | 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). | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Number | Percent of Change | Week 4 and End of study (up to Week 8) |
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| Secondary | 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). | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Number | Minutes | Week 4 and End of study (up to Week 8) |
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| Secondary | 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). | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Number | Nocturnal awakenings | Week 4 and End of study (up to Week 8) |
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| Secondary | Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE) | Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period. | Posted | Count of Participants | Participants | Up to Week 8 |
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| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA Ver. 20.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D005759 |
| Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
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| Participant C - Week 4 |
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| Participant C - End of study |
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| Participant B - Week 4 |
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| Participant B - End of study |
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| Participant C - Week 4 |
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| Participant C - End of study |
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| Participant B - Week 4 |
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| Participant B - End of study |
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| Participant C - Week 4 |
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| Participant C - End of study |
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