A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
- Conditions
- Non-Erosive Gastro-Esophageal Reflux DiseaseHeartburn
- Interventions
- Drug: Placebo
- Registration Number
- NCT04799158
- Lead Sponsor
- Phathom Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 458
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo: On-Demand Treatment Period Placebo Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take a placebo when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period. Run-In Period Vonoprazan Participants will receive vonoprazan 20 mg once daily for up to 4 weeks. Vonoprazan 20 mg: On-Demand Treatment Period Vonoprazan Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 20 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period. Vonoprazan 40 mg: On-Demand Treatment Period Vonoprazan Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 40 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period. Vonoprazan 10 mg: On-Demand Treatment Period Vonoprazan Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 10 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period.
- Primary Outcome Measures
Name Time Method Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug On-Demand Treatment Period: Day 1 to Day 42 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.
- Secondary Outcome Measures
Name Time Method Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours After Taking Study Drug On-Demand Treatment Period: Day 1 to Day 42 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.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 On-Demand Treatment Period: Day 1 to Day 42 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.Mean Number of Tablets of Rescue Antacid Taken Per Day Over the On-Demand Treatment Period 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 On-Demand Treatment Period: Day 1 to Day 42 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.Percentage of Days Study Drug Was Taken Over the On-Demand Treatment Period On-Demand Treatment Period: Day 1 to Day 42 Percentage of 24-Hour Heartburn-Free Days Over the On-Demand Treatment Period On-Demand Treatment Period: Day 1 to Day 42 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.
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Trial Locations
- Locations (60)
North Alabama Research Center LLC
🇺🇸Athens, Alabama, United States
OM Research LLC
🇺🇸Lancaster, California, United States
Medication Management LLC
🇺🇸Greensboro, North Carolina, United States
Care Access
🇺🇸Chicago, Illinois, United States
Sierra Clinical Research - ClinEdge
🇺🇸Las Vegas, Nevada, United States
Site 1
🇺🇸Las Vegas, Nevada, United States
Synergy Group US, LLC
🇺🇸Houston, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Quality Research Inc
🇺🇸San Antonio, Texas, United States
Paragon Rx Clinical, Inc.
🇺🇸Santa Ana, California, United States
Del Sol Research Management - Clinedge
🇺🇸Tucson, Arizona, United States
ENCORE Borland-Groover Clinical Research
🇺🇸Jacksonville, Florida, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
Clinical Research Center of Florida
🇺🇸Pompano Beach, Florida, United States
In Quest Medical Research
🇺🇸Suwanee, Georgia, United States
Guardian Angel Research Center
🇺🇸Tampa, Florida, United States
GI Associates and Endoscopy Center
🇺🇸Flowood, Mississippi, United States
Florida Medical Clinic, LLC Clinical Research Division
🇺🇸Zephyrhills, Florida, United States
Advanced Research Institute
🇺🇸Sandy, Utah, United States
Carolina Research
🇺🇸Greenville, North Carolina, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
GW Research, Inc
🇺🇸Chula Vista, California, United States
Imagine Research of Palm Beach County
🇺🇸Boynton Beach, Florida, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
ClinCloud
🇺🇸Maitland, Florida, United States
Clinical Trials Management LLC
🇺🇸Metairie, Louisiana, United States
Investigative Clinical Research
🇺🇸Annapolis, Maryland, United States
Peters Medical Research, LLC
🇺🇸High Point, North Carolina, United States
Site 2
🇺🇸Las Vegas, Nevada, United States
Gastroenterology Research of San Antonio (GERSA)
🇺🇸San Antonio, Texas, United States
Frontier Clinical Research, LLC
🇺🇸Uniontown, Pennsylvania, United States
Remington Davis Inc
🇺🇸Columbus, Ohio, United States
Virginia Gastroenterology Institute
🇺🇸Suffolk, Virginia, United States
Javara Inc
🇺🇸Charlotte, North Carolina, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Sherman Clinical Research
🇺🇸Sherman, Texas, United States
Elite Clinical Studies, LLC
🇺🇸Phoenix, Arizona, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
Clinical Research Associates Inc
🇺🇸Nashville, Tennessee, United States
Advanced Gastroenterology Associates, LLC
🇺🇸Palm Harbor, Florida, United States
Preferred Research Partners - ClinEdge
🇺🇸Little Rock, Arkansas, United States
Pinnacle Research Group
🇺🇸Anniston, Alabama, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
Medical Affiliated Research Center Inc
🇺🇸Huntsville, Alabama, United States
eStudySite
🇺🇸Chula Vista, California, United States
Riverside Clinical Research
🇺🇸Edgewater, Florida, United States
Paragon Rx Clinical
🇺🇸Garden Grove, California, United States
Western States Clinical Research Inc
🇺🇸Wheat Ridge, Colorado, United States
G. Medical Center
🇺🇸Orlando, Florida, United States
Iowa Digestive Disease Center
🇺🇸Clive, Iowa, United States
Gastroenterology Associates of Western Michigan, PLC
🇺🇸Wyoming, Michigan, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
IACT Health
🇺🇸Columbus, Georgia, United States
Trial Management Associates LLC
🇺🇸Wilmington, North Carolina, United States
Inquest Clinical Research
🇺🇸Baytown, Texas, United States
Rapid City Medical Center LLP
🇺🇸Rapid City, South Dakota, United States
Rio Grande Gastroenterology
🇺🇸McAllen, Texas, United States
Precision Clinical Research, LLC
🇺🇸Sunrise, Florida, United States
Legacy Clinical Solutions: Tandem Clinical Research, LLC
🇺🇸Marrero, Louisiana, United States
Family Medicine Associates of Texas
🇺🇸Carrollton, Texas, United States