A Study in Patients With Erosive Esophagitis to Investigate Safety, Tolerability, and Healing Rat… (NCT05055128) | Clinical Trial Compass
CompletedPhase 2
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
United States, Bulgaria248 participantsStarted 2021-08-11
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Body mass index (BMI) ≥ 18 and ≤ 40 kg/m\^2 at screening.
✓. Gastro-esophageal reflux disease with endoscopically confirmed esophagitis:
✓. Willing and able to comply with all aspects of the protocol (including capsule swallowing, diary completion, etc.).
✓. Capable of signing informed consent form.
Exclusion criteria
✕. History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease or disorder.
✕. Patients with so-called "alarm features" in symptomatology, like odynophagia, severe dysphagia, bleeding, weight loss, anemia, and blood in stool pointing to a possible malignant disease of the gastrointestinal (GI) tract.
✕. Presence of esophageal ulcer, stricture, Barrett´s esophagus or suspected esophagitis secondary to infection, inflammatory disease, ingestion of erosive chemicals or history of any surgical or medical condition which might significantly alter the Gastro-oesophageal reflux disease (GERD) status or the absorption, distribution, metabolism or excretion of drugs.
✕. Any planned major surgery within the duration of the study.
✕. History of a positive result for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), antibody to Hepatitis B core antigen (anti-HBcAg), or antibody to Hepatitis C virus (anti-HCV) or presence of these findings on screening.