11 results
Primary objectiveTo determine the effect of multiple dose OME on the pharmacokinetics (AUC0-8h, Cmax, C8h) of BOC.Secondary objectives:To determine the effect of steady state BOC on the pharmacokinetics (AUC0-8h, Cmax, C8h) of multiple dose OME.To…
Objective 1: To investigate the difference in prescribing proton pump inhibitors continuously rather than on demand in patient reported reflux symptoms, quality of life and self-rated health. Objective 2: To investigate whether the use of electronic…
The primary objective of the ERY-PAO study is to investigate the pharmacokinetics of acetylsalicylic acid (ASA) and omeprazole in morbidly obese subjects before and after RYGB surgery and to compare these data to study if there are differences in…
Phase I study to investigate safety of the combination indomethacin and two platinum-based chemotherapy regimens in patients with advanced cancers.
Primary objective• Determine the change in intratumoral T-cell (CD4, CD8 and Treg) and Myeloid cell (M1/M2 Macrophage, MDSC, DC) numbers and function between the baseline biopsy and the surgical specimen.Secondary objectives• PBMC before start…
The primary objective in the glucocorticoid-continuing subpopulation of men and women treated with chronic glucocorticoid therapy (>= 7.5 mg daily prednisone or its equivalent for >= 3 months and are planning to continue treatment for…
Primary:to examine the effect of co-administration with omeprazole on the pharmacokinetics of SSP-002358.Secondary:to provide additional safety information for SSP-002358 when administered alone or in combination with omeprazole.
Does single subcutaneous injection with denosumab or placebo (NACL 0.9%) induces a shorter Total contact cast treatment duration and faster bonefracture healing (days) and does it prevent deformation of the foot in patients with Charcot foot
Primary Objectives:• To assess the efficacy of soticlestat in reducing major motor drop (MMD) seizure frequency as add-on therapy to SOC as compared with placebo during the full treatment period (titration + maintenance).For European Medicines…
Primary Objective:To assess the long-term safety and tolerability of soticlestat when administered as adjunctive therapy to standard of care (SOC) (eg, antiseizure medications [ASMs], vagus nerve stimulation, ketogenic diet, or modified Atkins diet…
Primary Objectives:• To assess the efficacy of soticlestat in reducing convulsive seizure frequency as add-on therapy to SOC as compared with placebo during the full treatment period (titration + maintenance).• To assess the efficacy of soticlestat…