A Phase 3 interventional study of Linaprazan glurate - High dose and Linaprazan glurate - Low dose in GERD (Gastroesophageal Reflux Disease), sponsored by Cinclus Pharma Holding AB. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Cinclus Pharma Holding AB · Phase 3, Interventional, and Other
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:
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:
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.
An individual who has participated in a preceding linaprazan glurate healing trial will be asked to participate in this maintenance trial if the following criteria apply:
Exclusion Criteria:
An individual who has participated in a preceding linaprazan glurate phase 3 healing trial can be enrolled in this maintenance trial unless they meet any of the following exclusion criteria:
Solitary esophageal ulcer in the proximal two-thirds of the esophagus, untreated Barrett's esophagus or any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture.*
*Note: Participants with diagnosis of Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate, unless history of dilatation within 3 months of the Run-in Period.
History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, neurological disease or disorder, or psychiatric diagnosis which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the trial results or the participant's ability to participate in the trial. The following examples are conditions that would exclude the participant from participating:
Drug: Linaprazan glurate - High dose
Drug: Linaprazan glurate - Low dose
Drug: Lansoprazole - Marketed approved dose
Linaprazan glurate - High dose administered as per protocol
Linaprazan glurate - Low dose administered as per protocol
Lansoprazole administered as per protocol
Maintained healing of EE after 24 weeks as assessed by central reading of endoscopy.
Time frame: From enrollment to the end of 24 weeks of treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Cinclus Pharma Holding AB