16 results
To compare one dose of the short acting tropicamide combined with one dose of the longer acting cyclopentolate (c+t) with a double dose of the longer acting cyclopentolate (c+c). To develop a cycloplegics protocol that garantees optimal refractieve…
The objective of this trial is to investigate whether Eltrombopag added to standard immunosuppressive treatment increases the rate of early (at three months) complete response and blood counts and can be use as front-line therapy for SAA treatment.
To provide continuing treatment with eltrombopag for subjects who are currently participating in a GSK sponsored investigational study of eltrombopag (parent study) and to collect long term safety data.
Part 1 (open-label, 8 week): safety and tolerability of eltrombopag, optimal dose escalation scheme for use in Part 2, PK.Part 2: Primary: the reduction in the number of clinically relevant thrombocytopenic events (*Grade 3 hemorrhagic adverse…
At this time, iontophoretic administration of S(+)-ketamine is a already in use as a treatment of peripheral neuropathic pain in several pain clinics In the Netherlands (including the pain clinic at the Medical Center in Alkmaar). Although this…
To compare the effectiveness of 1) double dose of cyclopentolate and 2) one dose of cyclopentolate and one dose of tropicamide with 3 days, total 5 doses atropine.To investigate whether one dose of tropicamide combined with cyclopentolate is as…
Core StudyPrimary objective• To compare the efficacy of E5501 (in addition to standard of care) to eltrombopag (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic thrombocytopenic…
- To evaluate the relative bioavailability between the new eltrombopag capsule formulation (CPS) and the marketed tablet formulation (FCT) at single oral doses of 25 mg and 75 mg, in healthy subjects in the fasted state.- To evaluate the PK…
Primary: To evaluate the efficacy of eltrombopag + cyclosporine as first-line therapy on overall hematologic response (neutrophil, platelet, hemoglobin) by 6 months.Secondary: Overall hematologic response (neutrophil, platelet, hemoglobin) by 3 and…
To compare the effect of eltrombopag and IVIG on the achievement of the platelet count threshold before and after surgery.
The proposed study aims to examine the antidepressant efficacy of oral S-ketamine augmentation in patients with TRD treated with regular antidepressants in a double-blind randomised controlled trial. Secondary questions involve the effects of oral S…
The primary objective is to investigate whether pharmacological conditioning with S(+)-ketamine compared to pharmacological conditioning with placebo medication reduces pain sensitivity in patients with FMS.
Objective: Primary objective: To determine pharmacokinetic profiles of an esketamine oral thin film with 50 or 100 mg esketamine; Secondary objective: (1) To determine the pharmacodynamic profile of an esketamine oral thin film containing 50 or 100…
To characterize the PK of eltrombopag at steady state after oral administration in pediatric patients with SAA.Secondary (key only, see protocol page 40-41 for all objectives): Safety and tolerability. Efficacy (overall response rate ORR).
Evaluation of the feasibility of a trial on the efficacy of oral esketamine for the treatment of depression and/or demoralization in patients with advanced cancer who receive palliative care.
The purpose of this study is to assess the efficacy and safety of ianalumab (VAY736) compared to placebo in addition to second-line eltrombopag in adults with primary immune thrombocytopenia