3 results
The primary efficacy variable is the change in PV from baseline as assessed by 3 D ultrasonography after 78 weeks of double-blind treatment with OM 20-40 mg daily compared to ATE 50-100 mg daily.Secondary efficacy variables:Change from baseline PV…
The main objectives of this study are:1. The effect of high (2L) vs low (1L) volume bowel preparation on the quality of life of patients undergoing colonoscopy. 2. The cost-effectiveness of low-volume bowel preparation versus high-volume preparation…
Part A: healthy volunteers (n=up to 15)Primary/safety objective: - To assess the safety, tolerability and pharmacokinetics of a single IV dosage of OTL78 Secondary objective: - To assess the pharmacodynamics of OTL78 by measuring the temporal…