8 results
VIKS-2A:To determine the optimal dosage of vitamin K for supplementation to obtain a stable anticoagulation effect.VIKS-2B:To determine whether supplementation with the found optimal dosage of vitamin K from study VIKS-2A will decrease the number of…
1. Determining whether or not the vitamin K tablets have the same biological availability in humans as the vitamin K solution has.2. Determining whether or not the vitamin K tablets are as effective as the vitamin K solution is.
Primary Objective: - to study the influence of administration aprepitant (Emend ®) on the clearance of fentanyl, in patients using a stable dose of the fentanyl patch (Durogesic ®).Stable dose is defined as using the same dose of fentanyl during at…
Coprimary: The coprimary objectives of the study are to evaluate the efficacy of ontamalimab as maintenance treatment in subjects with moderate to severe Crohn*s disease (CD) based on:* Clinical remission based on 2 item patient-reported outcome (…
Coprimary: The coprimary objectives of this study are to evaluate the efficacy of ontamalimab in subjects with moderate to severe Crohn*s disease (CD) in:* Inducing clinical remission based on 2 item patient reported outcome (PRO) (abdominal pain…
To evaluate the safety and tolerability of long term treatment with ontamalimab in subjects with moderate to severe UC or CD.
Primary: To evaluate the efficacy of ontamalimab in inducing remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).Key Secondary:* To evaluate the…
Primary: To evaluate the efficacy of ontamalimab as maintenance treatment of remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).Key Secondary:*…