Crohn's disease
Conditions
Brief summary
Percentage of patients with no endoscopic and histopathological changes in the esophagus and/or stomach and/or duodenum
Detailed description
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.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with no endoscopic and histopathological changes in the esophagus and/or stomach and/or duodenum | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Poland