Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Launched by DR. FALK PHARMA GMBH · Sep 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to compare two different dosing schedules of budesonide orodispersible tablets for treating eosinophilic esophagitis (EoE), a condition that causes inflammation in the esophagus. Specifically, the study aims to see if taking 1 mg of budesonide twice a day for six weeks is just as effective as taking 2 mg once a day in helping patients achieve remission from their symptoms. The trial is currently seeking adults aged 18 to 75 who have been diagnosed with active EoE and are experiencing symptoms.

Eligible participants will need to provide informed consent and have a confirmed diagnosis of EoE. They should not have other related gastrointestinal diseases or conditions that could complicate their treatment, such as gastroesophageal reflux disease (GERD) or certain infections. If you decide to join the study, you can expect to take the medication as prescribed and attend follow-up visits to monitor your progress. It's important to note that participants will be carefully monitored throughout the trial to ensure their safety and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent,
• • Male or female patients, 18 to 75 years of age,
• • Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
• • Active symptomatic and histological EoE
• • Negative pregnancy test in females of childbearing potential at baseline visit.
• Exclusion Criteria:
• • Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
• • Achalasia, scleroderma esophagus, or systemic sclerosis,
• • Other clinically evident causes than EoE for esophageal eosinophilia,
• • Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \[candida esophagitis\]),
• • Any relevant systemic disease (e.g., AIDS, active tuberculosis, hepatitis B or C),
• • If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
• • Liver cirrhosis or portal hypertension,
• • History of cancer in the last five years,
• • History of esophageal surgery at any time or of esophageal dilation procedures within the last 4 weeks prior to screening visit, or need for an immediate endoscopic intervention due to a stricture
• • Upper gastrointestinal bleeding within 8 weeks prior to baseline visit,
• • Existing or intended pregnancy or breast-feeding.