To evaluate the efficacy and safety of vonoprazan compared to lansoprazole in participants with erosive esophagitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,027
Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Over-encapsulated capsule administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.
Time frame: Week 8
Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.
Time frame: Week 24
Healing Phase: Percentage of 24-hour Heartburn-free Days
A 24-hour heartburn-free day was defined as a day having no heartburn among all diary entries for that day. The percentage of 24-hour heartburn-free days was calculated using all days with at least 1 evening or morning diary entry during the treatment period of this phase.
Time frame: Day 1 to Week 8
Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE at Week 2
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. LA Classification of Esophagitis Grading Scale: Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference. Grade D: One or more mucosal breaks, which involves at least 75% of the circumference.
Time frame: Week 2
Healing Phase: Percentage of Participants With Onset of Sustained Resolution of Heartburn by Day 3
Sustained resolution was defined as at least 7 consecutive days with no daytime or night time heartburn as assessed by the daily diary. A participant was considered to have sustained resolution of heartburn by Day 3 if the first day of the 7 consecutive days without symptoms was on Days 1, 2, or 3.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pinnacle Research Group
Anniston, Alabama, United States
North Alabama Research Center LLC
Athens, Alabama, United States
Synexus Clinical Research US, Inc.
Birmingham, Alabama, United States
Medical Affiliated Research Center Inc
Huntsville, Alabama, United States
Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
Chandler, Arizona, United States
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
Mesa, Arizona, United States
Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
Mesa, Arizona, United States
Elite Clinical Studies - Phoenix - BTC - PPDS
Phoenix, Arizona, United States
Hope Research Institute LLC
Phoenix, Arizona, United States
Del Sol Research Management - BTC - PPDS
Tucson, Arizona, United States
...and 147 more locations
Time frame: Day 1 to maximum of Day 10 (inclusive of 7 day heartburn assessment)
Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE by Week 8
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. LA Classification of Esophagitis Grading Scale: Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference. Grade D: One or more mucosal breaks, which involves at least 75% of the circumference.
Time frame: Week 8
Healing Phase: Percentage of Participants Who Had Complete Healing of EE at Week 2
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.
Time frame: Week 2
Maintenance Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Maintained Complete Healing of EE at Week 24
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. LA Classification of Esophagitis Grading Scale: Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference. Grade D: One or more mucosal breaks, which involves at least 75% of the circumference.
Time frame: Week 24
Maintenance Phase: Percentage of 24-hour Heartburn-free Days
A 24-hour heartburn-free day was defined as a day having no heartburn among all diary entries for that day. The percentage of 24-hour heartburn-free days was calculated using all days with at least 1 evening or morning diary entry during the treatment period of this phase.
Time frame: Day 1 to Week 24