Reflux esophagitis
Conditions
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Changes from Start of Administration (Week 0) in Pittsburgh Sleep Quality Index (PSQI) Global Score at End of Study Timeframe: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Changes from Start of Administration (Week 0) in PSQI Global Score at Week 4 Timeframe: 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. efficacy Percentage of Participants with PSQI Global Score <6.0 at Week 4 and End of Study Timeframe: 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. efficacy Changes from Start of Administration (Week 0) in C1: Sleep Quality of PSQI Global Score at Week 4 and End of Study Timeframe: 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. efficacy Changes from Start of Administration (Week 0) in C2: Sleep Latency of PSQI Global Score at Week 4 and End of Study Timeframe: 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, | — |
Countries
Japan
Outcome results
None listed