Search for a trial

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-983 Followed by an Open-Label, Randomized, Crossover Study to Estimate the Effect of Steady State Administration of VX-983 on the Pharmacokinetics of a Single, Oral Dose of Midazolam in Healthy Adult Subjects

The study will consist of three parts, part A, B and C. The main purpose of the study is to investigate to what extent VX-983 is safe and tolerated. In addition, it will be investigated how quickly and to what extent VX-983 is absorbed and…

A double blind, placebo controlled, double dummy, randomized, crossover trial to investigate the pharmacokinetics, pharmacodynamics and tolerability of a novel intranasal midazolam formulation in healthy adult subjects

• To determine the onset of action of IN MDZ as compared to IV MDZ.• To determine extend and duration of the sedative effects of 2.5 mg and 5 mg IN MDZ. • To estimate the absolute and relative bioavailability and dose proportionality of single doses…

A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH MIDAZOLAM FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT

Primary objective:The study has hierarchical co-primary objectives to demonstrate that:- Firstly: dexmedetomidine is at least as effective as sedation with midazolam and daily sedation stops, in maintaining a target depth of sedation in ventilated…

Treatment of Complex Regional Pain Syndrome type I;A randomised, double-blind, placebo-controlled study with multiple rounds of S(+)-ketamine infusions (The Ket Ket Study)

Primary aim:The primary aim of this study is to evaluate the effect of two consecutive infusions of S(+)-ketamine in patients with CRPS-I on pain relief. The design of the study is prospective, randomised, double-blind and placebo-controlled.…

A double blind, randomised, multicentre, active controlled, parallel-group, phase III trial to evaluate the efficacy, safety and pharmacokinetics of clonidine (hydrochloride) for sedation in children from birth to less than 18 years of age

Primary:To assess the non-inferiority of the sedative properties of continuous intravenous (i.v.) clonidine compared to continuous i.v. midazolam in mechanically ventilated children and adolescents (0 - <18 years) admitted to a paediatric…

Reducing pain and discomfort during and after bone marrow aspiration

The main objective of this study is to investigate which premedication scheme reduces best the pain during and after a BMAB and reduces best the fear for a possible next BMAB. Other objectives are the influence of the different medication schemes on…

A Double Blind, Ascending Multiple Dose Study to Evaluate the Safety and Tolerability of GAL-021 in Healthy Volunteers.

Primary objectives:1) To evaluate the safety and tolerability of multiple doses GAL-021 in healthy volunteers.2) To evaluate the pharmacokinetic profile of multiple doses of GAL-021 in healthy volunteers.3) To evaluate the pharmacodynamic effects at…

A Phase 1, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses Oral Doses of APX001, to Investigate the Effect of Food on APX001 and to Investigate the Drug-Drug Interaction Potential of APX001

The study will be performed in 3 parts, Parts 1, 2 and 3. In all parts, the purpose is to investigate to what extent APX001 is tolerated. In addition, it will be investigated how quickly and to what extent APX001 is absorbed and eliminated from the…