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

Condition(s) studied

Investigational drug(s) / intervention(s)

Linaprazan glurate 50 mg Twice Daily (BID): Participants in this group will receive a total daily dose of 100 mg of linaprazan glurate, administered as 50 mg in the morning and 50 mg in the evening. In the morning, they take one 50 mg linaprazan glurate tablet along with a placebo capsule that matches the appearance of the lansoprazole capsule. In the evening, they take another 50 mg linaprazan glurate tablet, without any additional placebo.

Linaprazan Glurate 50 mg Once Daily (QD): Participants in this group will receive a total daily dose of 50 mg of linaprazan glurate, taken once daily in the morning. In the morning, they take one 50 mg linaprazan glurate tablet along with a placebo capsule that mimics the lansoprazole capsule. In the evening, they take a placebo tablet that mimics the appearance of the linaprazan glurate tablet.

Lansoprazole 30 mg Once Daily (QD): Participants in this group will receive a total daily dose of 30 mg of lansoprazole, taken once daily in the morning. In the morning, they take one 30 mg lansoprazole capsule along with a placebo tablet that mimics the linaprazan glurate tablet. In the evening, they take another placebo tablet resembling linaprazan glurate.

Study summary

The goal of this clinical trial is to find out how well linaprazan glurate can heal erosive esophagitis (EE) caused by gastroesophageal reflux disease (GERD), compared to lansoprazole, a commonly used medication. Researchers will also evaluate whether linaprazan glurate:

* Reduces heartburn symptoms more effectively than lansoprazole
* Is safe and well tolerated, based on physical exams, blood tests, and vital signs (heart rate, blood pressure, temperature, and breathing rate)
* Causes any side effects during treatment
* Has different effects depending on how much of the drug is in the blood
* Works differently depending on participants' genes

Participants must be between 18 to 80 years old and have EE due to GERD confirmed by an endoscopy. Participants cannot join if they have an active Helicobacter pylori (HP) infection or were treated for HP in the past 6 weeks or have taken antibiotics or bismuth-containing drugs in the past 6 weeks.

The study is a randomized, double-blind, active comparator-controlled trial lasting up to 4 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 (about 167 people in each group):

* Linaprazan glurate 50 mg twice a day
* Linaprazan glurate 50 mg once a day
* Lansoprazole 30 mg once a day

Everyone will take 2 tablets and 1 capsule by mouth daily for 8 weeks. Some tablets or capsules will be placebos (look like medicine but contain no active drug). Participants will:

* Undergo an endoscopy in the beginning and after 4 weeks of treatment
* If healing is not observed, another endoscopy may be done at 8 weeks
* During the procedure, doctors will use a thin, flexible tube with a camera to look at the esophagus and take small tissue samples (biopsies)
* Have blood and urine tests at clinic visits to check overall health
* Receive electrocardiograms (ECGs) to monitor heart function
* Complete daily questionnaires on an electronic device about symptoms and experiences

Eligibility

Primary outcome measure(s)

• Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D. — From enrollment to the end of treatment at 4 weeks.

Trial sites (87)

+ 47 more sites — see the full list on the official registry below.

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