Crohn's disease MedDRA version: 20.0 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: The IMP is authorized but for a different indication and route of administration. IMP will be budesonide in nebulized suspension but for oral administration. The idea is local action, low
Sponsors
Medical University of Warsaw
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -age 6-18; -CD diagnosed according to commonly accepted criteria from Porto, taking into account clinical, endoscopic and histopathological criteria; inflammatory changes in the esophagus and/or stomach and/or duodenum found in an endoscopic examination (assessed by 2 - independent endoscopists) and confirmed in a histopathological examination (on the Paris scale CD-C activity: L4a, i.e. involvement of the upper gastrointestinal tract to the Treitz ligament); - if a previous examination is used - the histopathological result cannot be older than 31 days before randomization; -stable, understood as no treatment modification, CD treatment for =2 weeks; exclusion of causes of inflammatory changes in the esophagus and/or stomach and/or duodenum other than CD, such as: reflux esophagitis, esophagitis herpetiformis, cytomegalovirus esophagitis, eosinophilic esophagitis and/or gastroduodenitis, Helicobacter pylori infection; -informed consent of the child's parents or guardians to participate in the study; for children = 16 years of age additionally, the consent of the child participating in the study declaration of sexual abstinence during the entire participation in the study Are the trial subjects under 18? yes Number of subjects for this age range: 138 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: age 18 years of age; other causes of inflammatory changes in the esophagus and/or stomach and/or duodenum, other than CD, such as reflux esophagitis, esophagitis herpetiformis, cytomegalovirus esophagitis, eosinophilic esophagitis and/or gastroduodenitis, infection Helicobacter pylori; use of general steroids up to 30 days prior to study entry; use of inhaled steroids up to 30 days prior to study entry; PPI use up to 30 days prior to study entry; acute viral or bacterial infection up to 30 days prior to study entry; morning cortisol <5 ug/dL; lack of informed consent of the child's parents or guardians to participate in the study; for children =16 years of age lack of consent of the child to participate in the study. patient's pregnancy; breastfeeding; lack of consent of a woman of reproductive age or a fertile man to follow contraceptive recommendations during the examination; the patient has had cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: THE OBJECTIVE OF THE STUDY IS TO ASSESS THE EFFECTIVENESS OF TOPICALLY APPLIED BUDESONIDE IN THE TREATMENT OF INFLAMMATIVE LEASES IN THE OESPHAGOM AND/OR THE GASTRIC AND/OR THE DUDENUM IN CHILDREN WITH LESNIOWSKI-CROHN'S DISEASE;Secondary Objective: not applicable;Primary end point(s): Percentage of patients with no endoscopic and histopathological changes in the esophagus and/or stomach and/or duodenum ;Timepoint(s) of evaluation of this end point: in the 8th week of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - the proportion of patients with no evidence of endoscopic changes in the esophagus, stomach, duodenum, respectively (which were present at entry into the tests) - 8th week; - percentage of patients with no histopathological changes in the esophagus, stomach, duodenum, respectively (which were present at entry into the study) - 8th week; - disease activity assessed on the PCDAI scale (Pediatric Crohn Disease Activity Index) assessed in the 8th week; - the percentage of patients whose upper gastrointestinal symptoms disappeared - 4th, 8th, 12th week; - a percentage of patients with adverse effects of steroids - 4th, 8th, 12th week; - assessment of treatment tolerance on a 10-point VAS scale - 4th, 8th week.;Timepoint(s) of evaluation of this end point: in the 4th, 8th and 12th week of the study | — |
Countries
Poland
Contacts
Public Contactclinical trial information desk
Medical University of Warsaw Klinika Gastroenterologii i Zywienia Dzieci
Outcome results
None listed