9 results
To assess the effect of amitriptyline on gastro-esophageal symptom severity and on esophageal sensitivity to acid perfusion and balloon distension in patients with documented functional heartburn.
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…
The aim is to determine on the basis of the results of this study whether there is measurable effect on the ability to drive after long term use of ICADTS class III drugs. To achieve this goal drugs will be tested out of the groups most commonly…
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…
To compare efficiency, side effects and costs of a strategy with amitriptyline as drug of first choice versus a strategy with pregabalin as drug of first choice.
Observe the adherence rate of antidepressants during pregnancy and secondary exploration of possible factors which contribute to non-adherence
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.
To determine whether polystyrene sulfonate has an effect on exposure of amitriptyline, when taken simultaneously, compared to amitriptyline taken alone in healthy volunteers, expressed in Cmax and AUC0-8h.
The purpose of this study is to investigate the effect size in order to perform a power calculation for calculating a sample size for a powered RCT