NCT04124926
Completed
Phase 3
A Phase 3, Randomized, Double-Blind, Two Phase, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 20 mg Compared to Lansoprazole 30 mg for Healing in Patients With Erosive Esophagitis and to Evaluate the Efficacy and Safety of Vonoprazan (10 mg and 20 mg) Compared to Lansoprazole 15 mg for the Maintenance of Healing in Patients With Healed Erosive Esophagitis
Phathom Pharmaceuticals, Inc.152 sites in 1 country1,027 target enrollmentStarted: October 28, 2019Last updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,027
- Locations
- 152
- Primary Endpoint
- Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24
Overview
Brief Summary
To evaluate the efficacy and safety of vonoprazan compared to lansoprazole in participants with erosive esophagitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The participant is ≥18 years of age at the time of informed consent signing.
- •In the opinion of the investigator or subinvestigators, the participant is capable of understanding and complying with protocol requirements.
- •The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side-effects. The participant has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
- •The participant is found to have endoscopically confirmed EE of LA Classification Grades A to D during the Screening Period (Visit 1) as assessed by a central adjudicator. The target number of participants with LA classification Grade C or D will be approximately 30% of the total number of participants (300 total). Enrollment of EE participants with Grade A or B will end when the number of participants with Grade A or B EE is approximately 700 or 70% of the total planned number of participants. Given the invasive nature of an endoscopy, any endoscopic confirmation performed in a routine clinical setting before signing the informed consent will be acceptable to use for the purpose of fulfilling the screening requirement if all of the following apply: (1) appropriate endoscopy pictures were taken; (2) appropriate gastric biopsy samples were taken; (3) the endoscopy pictures can be sent to the central adjudicator via the adjudication systems; and (4) all screening procedures (including the completion of adjudication) AND randomization can be completed within a 7-day period after the date of the endoscopy.
- •A female participant of childbearing potential who is or may be sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.
Exclusion Criteria
- •The participant's endoscopic examination for entering this study fails to confirm EE within 7 days (no later than 10 days on rare occasion with sponsor approval) prior to randomization.
- •The participant is determined to be positive for Helicobacter pylori (HP) or has had an HP infection within 45 days of randomization.
- •The participant has endoscopic Barrett's esophagus (\>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
- •The participant has any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma (including sclerotherapy or esophageal variceal band ligation). However, participants diagnosed with Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate.
- •The participant has scleroderma (systemic sclerosis).
- •The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
- •The participant has an active gastric or duodenal ulcer at the start of the Screening Period. Additionally, participants with gastric or duodenal erosions are permitted to participate.
- •The participant has received any investigational compound (including those in post marketing studies) within 30 days prior to the start of the Screening Period. A participant who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
- •The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
- •The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.
Arms & Interventions
Healing Phase: Vonoprazan 20 mg
Experimental
Participants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 8 weeks.
Intervention: Vonoprazan (Drug)
Healing Phase: Lansoprazole 30 mg
Active Comparator
Participants will receive oral lansoprazole 30 mg once per day (QD) for a maximum of 8 weeks.
Intervention: Lansoprazole (Drug)
Maintenance Phase: Vonoprazan 10 mg
Experimental
Participants will receive oral vonoprazan 10 mg once per day (QD) for a maximum of 24 weeks.
Intervention: Vonoprazan (Drug)
Maintenance Phase: Vonoprazan 20 mg
Experimental
Participants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 24 weeks.
Intervention: Vonoprazan (Drug)
Maintenance Phase: Lansoprazole 15 mg
Active Comparator
Participants will receive oral lansoprazole 15 mg once per day (QD) for a maximum of 24 weeks.
Intervention: Lansoprazole (Drug)
Outcomes
Primary Outcomes
Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24
Time Frame: Week 24
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.
Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8
Time Frame: Week 8
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.
Secondary Outcomes
- Healing Phase: Percentage of Participants Who Had Complete Healing of EE at Week 2(Week 2)
- Maintenance Phase: Percentage of 24-hour Heartburn-free Days(Day 1 to Week 24)
- Maintenance Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Maintained Complete Healing of EE at Week 24(Week 24)
- Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE at Week 2(Week 2)
- Healing Phase: Percentage of Participants With Onset of Sustained Resolution of Heartburn by Day 3(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(Week 8)
- Healing Phase: Percentage of 24-hour Heartburn-free Days(Day 1 to Week 8)
Investigators
Study Sites (152)
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