drugset / Trial / NCT05055128
A Study in Patients With Erosive Esophagitis to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will be conducted in patients with erosive esophagitis due to gastro-esophageal reflux disease (GERD) Los Angeles (LA) grades C or D, and in patients with at least partial symptom response but still endoscopically unhealed (LA grades A or B) after 8 weeks history of standard treatment healing course with PPI, designed to support dose selection for Phase 3 and to investigate safety, tolerability, and healing rates after 4 weeks treatment of X842 or Lansoprazole, and symptom pattern during subsequent 4 weeks treatment with Lansoprazole.
Timeline
- Start
- 2021-08-11
- Primary completion
- 2022-09-01
- Completion
- 2022-09-01
Publications
- Paper Alert. Eur J Gastroenterol Hepatol. 2025 Jul 1;37(7):887-890. doi: 10.1097/MEG.0000000000003011. Epub 2025 May 28.
- Sharma P, Vaezi M, Unge P, Andersson K, Larsson K, Popadiyn I, Rosenholm M, Rosztoczy A, Yektaei E, Armstrong D. Clinical Trial: Dose-Finding Study of Linaprazan Glurate, A Novel Potassium-Competitive Acid Blocker, Versus Lansoprazole for the Treatment of Erosive Oesophagitis. Aliment Pharmacol Ther. 2025 May;61(10):1590-1602. doi: 10.1111/apt.70109. Epub 2025 Apr 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lansoprazole | Other / unclassified | 30 mg | — |
| Subject | Linaprazan glurate | Small molecule | 25 mg | — |
| Subject | Linaprazan glurate | Small molecule | 50 mg | — |
| Subject | Linaprazan glurate | Small molecule | 75 mg | — |
| Subject | Linaprazan glurate | Small molecule | 100 mg | — |