6 results
The study has two objectives. Firstly, we will investigate the safety and tolerability of the study drug following administration of a single escalating dose of the drug. Secondly, we will investigate the rate at which the study drug is absorbed…
Primary • To investigate the safety and tolerability of long-term treatment with 1.5 mg or 3.0 mg of Org 50081 in elderly outpatients with chronic primary insomnia. Secondary • To collect exploratory efficacy data of long-term treatment with Org…
Primary: To demonstrate the long-term efficacy of treatment with Org 50081, as compared to placebo, on sleep maintenance in patients with chronic primary insomnia as measured by the subjective Total Sleep Time. Primary efficacy endpoint is the…
Primary: To investigate the pharmacokinetics of palonosetron in plasma from three different sizes of HP-3020 transdermal patch applied for 24 hours as compared to intravenous palonosetron (Cohort 1) and to investigate the pharmacokinetics of…
To investigate safety and tolerability and to collect exploratory efficacy data of long-term treatment with Org 50081 in adult patients with chronic primary insomnia.
In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antiemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed CINV induced by non-AC based…