A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

Phase 2

Completed

• Conditions: Non-Erosive Gastro-Esophageal Reflux Disease; Heartburn
• Interventions: Drug: Placebo; Drug: Vonoprazan

• 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

Study Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-16
• Study Start: 2021-03-25
• Primary Completion: 2021-12-16
• Study Completion: 2022-01-17
• Results First Submitted: 2022-10-31
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-08
• Last Update Submitted: 2022-12-08
• Results First Posted: 2023-01-04
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 458

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Trial Locations

Locations (60)

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

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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