20 results
To investigate the postoperative pain, compliance, satisfaction in the three different groups of postoperative analgesia and a possible interaction.
Primary objective:Can a difference between the change in the perception of pain over time (0-60 minutes) between tramadol and butylscopolamine in renal colic be proven?Secundary objectives:- Can a difference in the decline in VAS-score over time (0-…
To asses the comparability of the estimated dabigatran concentration in plasma via calibrated Hemoclot and the measured dabigatran concentrations assessed in a central lab in patients with moderate renal impairment undergoing primary unilateral…
See section 2.2. of the protocol.The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in NVAF patients undergoing AF…
To provide single dose PK/PD dataTo investigate tolerability and safety of dabigatran etexilate solution in children1 to <12 years of age
The primary objective of this study is to determine (differences in) patient satisfaction with pain relief and pain intensity (Numeric Rating Scale) using a step 1 vs. a step 2 based analgesic regimen.The secondary objective is to determine…
The aim of this phase I study is to assess the extent of intestinal absorption of rivaroxaban and dabigatran etexilate in adult patients with short bowel syndrome and treated with long-term TPN.
Primary Objective:What is the effectiveness of immediate opioid pain medication (followed by step-down) versus step-up pain medication within the treatment according general practitioners* clinical guideline in patients with (sub)acute sciatica,…
See section 2.2 of the protocol.The main objective of this study is to compare a DAT regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg DE-DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (…
The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…
To investigate the effect of dabigatran etexilate on airway inflammation, hemostasis and asthma control in patients with severe asthma.
The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…
To investigate whether oral administration of dabigatran etexilate in patients with a rhegmatogenous retinal detachment leads to clinical significant dabigatran levels and thrombin inhibiting activity in the vitreous and subretinal fluid.
The primary objective of this study is to determine (differences in) patient satisfaction with pain relief and pain intensity (Numeric Rating Scale) using a step 1 vs. a step 2 based analgesic regimen.The secondary objective is to determine…
To determine whether a single dose of 50 IE/Kg PCC is effective in reversing the anticoagulant effect of Dabigatran Etexilate 300mg b.i.d. taken for 2.5 days, as assessed by two modified skin bleeding assays: the "shed blood" and "…
Primary objectivePart A• Evaluating the effect and reproducibility of the capsaicin sensitization model on the predefined primary endpoints in both primary and secondary hyperalgesia areas for LS• Evaluating the effect and reproducibility of the…
Primary objectiveThe primary objective of this study is to assess the efficacy of gabapentin relative to tramadol for the treatment of moderate to severe chronic neuropathic or mixed pain in children from 3 months to less than 18 years of age.…
See protocol sectie 2.1 & 2.2
1) To collect continuous data2) To extract and describe features, patterns and relationships in the data3) To quantify relationships between vital signs and activity variables or exposure to air pollution4) To identify features, patterns and…
To evaluate management strategies in premenopausal women with heavy menstrual bleeding associated with factor Xa inhibitor therapy.