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A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks

ConditionSymptomatic Non-erosive Gastroesophageal Reflux Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhathom Pharmaceuticals, Inc.

About this trial

The main objective is to assess the efficacy of vonoprazan (10 mg as needed) compared to placebo (as needed) in relief of episodic heartburn at 2 hours that is sustained for 24 hours over 12 weeks of treatment in participants with non-erosive gastroesophageal reflux disease (GERD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The participant is ≥18 years of age at the time of informed consent signing.

In the opinion of the Investigator or Sub-investigators, the participant is capable of understanding and complying with protocol requirements, including compliance with the electronic diary.

The participant signs and dates a written informed consent form (ICF) 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 has a diagnosis of non-erosive GERD with heartburn as the participant's predominant symptom prior to the Screening Period as documented in the medical history and/or as assessed and documented by the Investigator (ie, medical records or other study related documents).

Disqualifiers

The participant has endoscopically confirmed erosive esophagitis (EE) during the Screening Period or was diagnosed with EE within 2 weeks prior to the Screening Period.

The participant has uncontrolled irritable bowel syndrome (IBS) or has had a flare of IBS requiring therapy within the prior 6 months.

Functional heartburn, as described in the Rome V criteria.

Functional dyspepsia, as described in the Rome V criteria.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vonoprazan

    Drug

    Oral tablet.

  • Placebo

    Drug

    Oral tablet.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Vonoprazan 10 mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Treated Heartburn Episodes Achieving Complete Relief at 2 Hours and Sustained Relief for 24 Hours up to Week 12

Time frame
Up to Week 12

Secondary outcomes

1

Percentage of Treated Heartburn Episodes Improved at 2 Hours With Sustained Relief for 24 Hours up to Week 12

Time frame
Up to Week 12
2

Percentage of Treated Heartburn Episodes Improved at 1 Hour With Sustained Relief for 24 Hours up to Week 12

Time frame
Up to Week 12
3

Percentage of Treated Heartburn Episodes Improved at 2 Hours up to Week 12

Time frame
Up to Week 12
4

Percentage of Treated Heartburn Episodes Improved at 1 Hour up to Week 12

Time frame
Up to Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Phathom Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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