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

NCT03116841 | Completed Phase 4 Results

• 3 other identifiers: Vonoprazan-4006U1111-1192-9760JapicCTI-173538
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 6

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.

Conditions

Reflux Esophagitis

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (13)

• Changes From Start of Administration (Week 0) in PSQI Global Score at Week 4

  From Week 0 to Week 4

• Percentage of Participants With PSQI Global Score <6.0 at Week 4 and End of Study

  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

  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

  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

  Week 0, Week 4 and End of study (up to Week 8)

Study Arms (1)

Vonoprazan 20 mg

EXPERIMENTAL

Vonoprazan 20 mg orally administered once daily

Drug: Vonoprazan

Interventions

Vonoprazan DRUG

Vonoprazan 20 mg

Vonoprazan 20 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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):
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> upper limit of normal (ULN)
• Bilirubin (Total bilirubin) \> ULN
• Participants with a malignant tumor.

Sponsors & Collaborators

• Takeda: lead

Study Sites (6)

Tokatsu Tsujinaka Hospital

Abiko, Chiba, Japan

Location

Amada Clinic

Kōriyama, Fukushima, Japan

Location

Aoyama Clinic

Kobe, Hyōgo, Japan

Location

Kashiwara Municipal Hospital

Kashihara, Osaka, Japan

Location

Saino Clinic

Tokorozawa, Saitama, Japan

Location

Masuyama Clinic

Ōtawara, Tochigi, Japan

Location

MeSH Terms

Conditions

Esophagitis, Peptic

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 17, 2017
• Study Start: August 2, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: March 29, 2019
• Results First Posted: March 29, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

JP (6)