RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.

Official Title

Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 Mg Once Daily Vs. 1 Mg Twice Daily Budesonide Orodispersible Tablets in Adults with Eosinophilic Esophagitis

Quick Facts

Study Start:2021-05-21
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06596252

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed informed consent,
  2. * Male or female patients, 18 to 75 years of age,
  3. * Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
  4. * Active symptomatic and histological EoE
  5. * Negative pregnancy test in females of childbearing potential at baseline visit.
  1. * Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
  2. * Achalasia, scleroderma esophagus, or systemic sclerosis,
  3. * Other clinically evident causes than EoE for esophageal eosinophilia,
  4. * Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \[candida esophagitis\]),
  5. * Any relevant systemic disease (e.g., AIDS, active tuberculosis, hepatitis B or C),
  6. * If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
  7. * Liver cirrhosis or portal hypertension,
  8. * History of cancer in the last five years,
  9. * 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
  10. * Upper gastrointestinal bleeding within 8 weeks prior to baseline visit,
  11. * Existing or intended pregnancy or breast-feeding.

Contacts and Locations

Study Contact

Sarah Burrack, Dr.
CONTACT
004976115140
zentrale@drfalkpharma.de

Principal Investigator

Alfredo J Lucendo, MD, PhD
STUDY_DIRECTOR
Department of Gastroenterology, Hospital General de Tomelloso, Spain

Study Locations (Sites)

Dr. Falk Investigational Site
La Jolla, California, 92037
United States
Dr. Falk Investigational Site
Lomita, California, 90717
United States
Dr. Falk Investigational Site
Houma, Louisiana, 70363
United States
Dr. Falk Investigational Site
Marrero, Louisiana, 70072
United States
Dr. Falk Investigational Site
Boston, Massachusetts, 02111
United States
Dr. Falk Investigational Site
Rochester, Minnesota, 55905
United States
Dr. Falk Investigational Site
Freehold, New Jersey, 07728
United States
Dr. Falk Investigational Site
Jackson, New Jersey, 08527
United States
Dr. Falk Investigational Site
New York, New York, 10032
United States
Dr. Falk Investigational Site
Chapel Hill, North Carolina, 27599-7080
United States
Dr. Falk Investigational Site
Cleveland, Ohio, 44195
United States
Dr. Falk Investigational Site
Harlingen, Texas, 78550
United States

Collaborators and Investigators

Sponsor: Dr. Falk Pharma GmbH

  • Alfredo J Lucendo, MD, PhD, STUDY_DIRECTOR, Department of Gastroenterology, Hospital General de Tomelloso, Spain

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-21
Study Completion Date2025-09

Study Record Updates

Study Start Date2021-05-21
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

  • Eosinophilic Esophagitis