4 results
Subjects randomized to the placebo treatment are unlikely to benefit from the study. However, OAB is not a life-threatening disease and it is not expected that a 12 to 15 week exposure to placebo treatment will have a negative impact on disease…
To assess the efficacy of Mirabegron 50mg versus Solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy.
Primary: Safety and tolerability.Secondary: Clinical and endoscopic remission, symptomatic clinical remission, clinical response, mucosal healing, health related QoL, CRP, faecal calprotectin, pharmacokinetics.
Primary Objective is to evaluate the efficacy of solifenacin 5mg in combination with mirabegron 50mg (referred to as combination therapy from here on) versus solifenacin 5mg monotherapy.Secondary Objectives are:- To evaluate the safety and…