9 results
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…
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…
To assess the impact of six IV infusions of 3, 6, or 12 mg/kg of CER-001 or placebo, given at weekly intervals, on atherosclerotic plaque volume, as measured by coronary IVUS.
Primary:- To assess the effect of TAK-861 on EDS as measured by sleep latency from the MWT.Secondary:- To assess the effect of TAK-861 on EDS as measured by the Epworth Sleepiness Scale (ESS) total score. - To evaluate the safety and tolerability of…
To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.
Primary Core: to demonstrate the efficacy of BAF312 relative to placebo in delaying the time to 3-month confirmed disability progression, measured by EDSS. Main secondary objectives Core: to demonstrate the efficacy in delaying the time to 3-month…
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…
Primary objective is: * To determine the overall survival (OS) benefit of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA.Secundary objectives are:* To determine the PFS benefit of PAG treatment…
* 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…