The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in relief of episodic heartburn over 6 weeks in participants with symptomatic non-erosive gastroesophageal reflux disease (NERD), and to assess the safety of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in participants with symptomatic NERD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
458
Orally via capsules
Orally via capsules
Pinnacle Research Group
Anniston, Alabama, United States
North Alabama Research Center LLC
Athens, Alabama, United States
Medical Affiliated Research Center Inc
Huntsville, Alabama, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Del Sol Research Management - Clinedge
Tucson, Arizona, United States
Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug
An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary. For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.
Time frame: On-Demand Treatment Period: Day 1 to Day 42
Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours After Taking Study Drug
An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary. For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug.
Time frame: On-Demand Treatment Period: Day 1 to Day 42
Percentage of Evaluable Heartburn Episodes for Each Participant That Are Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug
An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary. For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.
Time frame: On-Demand Treatment Period: Day 1 to Day 42
Mean Number of Tablets of Rescue Antacid Taken Per Day Over the On-Demand Treatment Period
Time frame: On-Demand Treatment Period: Day 1 to Day 42
Percentage of Participants With Complete Relief of Heartburn Within 3 Hours After the First Episode and With No Further Heartburn Reported for 24 Hours After Taking Study Drug
An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary. For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.
Time frame: On-Demand Treatment Period: Day 1 to Day 42
Percentage of Days Study Drug Was Taken Over the On-Demand Treatment Period
Time frame: On-Demand Treatment Period: Day 1 to Day 42
Percentage of 24-Hour Heartburn-Free Days Over the On-Demand Treatment Period
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: On-Demand Treatment Period: Day 1 to Day 42
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Preferred Research Partners - ClinEdge
Little Rock, Arkansas, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
GW Research, Inc
Chula Vista, California, United States
eStudySite
Chula Vista, California, United States
Paragon Rx Clinical
Garden Grove, California, United States
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