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A Study Comparing the Effect and Safety of Linaprazan Glurate to Lansoprazole in Maintenance of Healing in Participants With Healed Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD)

NCT07313774 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1050

Last updated 2026-01-07

No results posted yet for this study

Summary

The goal of this clinical trial is to investigate how well linaprazan glurate can maintain healed erosive esophagitis (EE) caused by GERD in participants who have participated in a prior healing trial, compared to lansoprazole (an approved treatment for GERD). Researchers will also examine:

* the effect of linaprazan glurate on heartburn symptoms compared to lansoprazole.
* whether linaprazan glurate treatment is safe and tolerable, based on symptoms and procedures such as blood and urine tests, endoscopy, and electrocardiograms (measure the heart's electrical activity). Endoscopy means that the doctor will insert a thin, flexible tube with a camera down the throat to look at each participant's esophagus area and collect small tissue samples (called biopsies).
* the side effects that may happen during treatment with linaprazan glurate.

Participants must be between 18 to 80 years old and have participated in a prior healing trial with healed EE (due to GERD) confirmed by an endoscopy either from the prior healing trial or from the initial period of this trial. Participants cannot participate if they are not healed, had to stop trial treatment because of a side effect in a prior healing trial, or if they have a condition that could make it unsafe.

The study is a randomized, double-blind, active comparator-controlled clinical trial lasting for almost 14 months. Randomized means that participants are assigned by chance (like flipping a coin) to one of the treatment groups and double-blind means neither the participants nor the study team will know which treatment is given. Participants will be placed into one of three groups:

* Linaprazan glurate - High dose
* Linaparazan glurate - Low dose, and
* Lansoprazole - marketed approved dose Everyone will take a total of 2 tablets and 1 capsule orally every day for up to 52 weeks. The tablets and capsule will be separated into a morning dose and an evening dose. Some tablets or capsules will be placebos (look like medicine but contain no active drug).

Participants will complete several questionnaires on an electronic device during treatment. An endoscopy will be performed after 24 weeks of treatment to determine if healing has been maintained. If healing has been maintained, the participant will continue taking trial treatment and another endoscopy will be performed at 52 weeks. If healing has not been maintained at 24 weeks or if the participant has reached 52 weeks, the participant will stop taking trial treatment and return for a follow up visit.

Conditions

  • GERD (Gastroesophageal Reflux Disease)

Interventions

DRUG

Linaprazan glurate - High dose

Linaprazan glurate - High dose administered as per protocol

DRUG

Linaprazan glurate - Low dose

Linaprazan glurate - Low dose administered as per protocol

DRUG

Lansoprazole - Marketed approved dose

Lansoprazole administered as per protocol

Sponsors & Collaborators

  • Cinclus Pharma Holding AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-09-30
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07313774 on ClinicalTrials.gov