17 results
The primary objective of this study is to evaluate whether adding intensive local anti-inflammatory therapy (Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks) to routine enteric balloon dilatation reduces…
Objectives:The objective of the trial is to evaluate efficacy and safety of two different doses of Nefecon® in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure…
To compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight plus budesonide (9mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. To study safety and…
To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.
Primary objective: To study the effects of budesonide on the incidence of cabazitaxel induced diarrhea Secondary objectives: To study the effects of budesonide on other side effects of cabazitaxel (e.g. myelotoxicity), To study the pharmacogenetics…
Primary objective- Survival without BPD at 36 weeks gestational age (GA)Secondary objectives- Neurodevelopment at a corrected age of 18-22 months- Adverse treatment effects- Mortality at 36 weeks gestational age- BPD incidence at 36 weeks…
Primary:* To assess the efficacy of 2 x 1 mg/d budesonide effervescent tablets vs. placebo for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis (EoE).Secondary:* To study safety and tolerability…
Primary:* To assess the efficacy of a 48-week treatment with 2 x 0.5 mg/d or 2 x 1 mg/d budesonide effervescent tablets vs. placebo for the maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis (EoE).Secondary…
To study the effect size of FMT after a 3 weeks course of budesonide as induction therapy in patients with active ulcerative colitis despite previous therapy. The purpose of the pre-treatment is to reduce active inflammation prior to donor feces…
* To demonstrate efficacy of budesonide (9 mg budesonide/d) vs. placebo for induction of remission in active incomplete microscopic colitis after 8 weeks of treatment* To study the maintenance of remission after end of treatment* To study safety and…
The Budesonide oral suspension is a new drug formulation especially developed for the treatment of eosinophile esophagitis in children and adolescents. The purpose of this clinical study is to investigate whether Budesonide oral suspension is…
Study AMAP is a single-arm, outpatient, open-label, Phase 3, multicenter, long-term extension study evaluating the efficacy and safety of mirikizumab in patients with moderately to severely active UC who have participated in an originator…
Primary for Platform-Level Exploratory Analysis1. To evaluate whether treatment with IL-23 inhibitors is superior to adult placebo in achieving clinical remission and endoscopic response in pediatric participants with moderately to severely active…
The main reason for this study is to help in answering the following research question: - Whether mirikizumab can help patients with Crohn*s disease when taken for a longer time. - How safe mirikizumab is and whether you might have any side effects…
MAIN Trial:Primary:To evaluate whether the efficacy of mirikizumab is superior to placebo in participants with Crohn's disease as assessed by- clinical response by patient reported outcome (PRO) at Week 12 andendoscopic response at Week 52-…
The objective of the study is to investigate whether the use of budesonde orodispergible tablets after ESD can prevent the devolpment of oesophageal strictures
Primary Objective To demonstrate that ICS can be safely withdrawn in T2-low asthma patients with obesity in secondary care (i.e. without loss of asthma control).Secondary Objectives1. To determine predictive factors for successful ICS withdrawal.2.…