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A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

The primary objective is to demonstrate superiority in overall survival of amrubicin (40 mg/m2 administered as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course) compared with topotecan hydrochloride (…

The effectiveness of antidepressants and psychological interventions in treating conversion disorder, motor type: a randomized placebo controlled clinical trial.

To examnine the effectiveness of psychological interventions and psychopharmacological interventions compared to placebo-control.

A multi-center, parallel-group, comparative trial evaluating the efficacy, pharmacokinetics and safety of 4.0 mg.kg-1 sugammadex administered at 1-2 PTC in subjects with normal or severely impaired renal function

Objective is to show equivalence with respect to the efficacy of sugammadex in subjects with normal or severely impaired renal function, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.

Prevention of constipation during treatment with opioids: magnesiumoxide versus macrogol/elektrolytes

The aim of the study is to compare magnesiumhydroxide and polyethylene glycol/electrolytes with regard to the prevention of constipation and side-effects in palliative care cancer patients starting with opioids.

GRACE (Genomics to combat Resistance against Antibiotics in Community-acquired LRTI in Europe).Workpackage 10: Antibiotic Trial One

The aim is to understand which individuals benefit from antibiotics.

Peripheral targeting of inhaled rhDNase for chronic obstructive asthma in childhood.

Primary Objective: To investigate the effect of treatment with nebulized rhDNase on pulmonary function in children with asthma and persistent obstructive pulmonary function.Secondary Objectives: To investigate the effect of treatment with nebulized…

MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

The purpose of this study is to identify the first time-point the OMERACT RAMRIS score for the activity of synovitis is statistically significantly reduced compared to Baseline, in response to cerolizumab pegol (CZP) therapy. In addition, the early…

Renal hemodynamic effects of aliskiren (rasilez) in comparison to ramipril (tritrace) in patients with overweight/obesity and hypertension

The primary objective of this study is to determine the effects of aliskiren, as compared to ramipril, on renal hemodynamics in overweight/obese and hypertensive patients.

A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element*) for the Treatment of up to two De Novo Coronary Artery Lesions

To determine the safety and effectiveness of the PROMUS Element* Everolimus-Eluting Coronary Stent System (Boston Scientific Corporation [BSC], Natick, MA) for the treatment of patients with up to 2 de novo atherosclerotic lesions

A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension

Primary objective• To demonstrate that either dose of ACT-064992 prolongs the time to the first morbidity or mortality event in patients with symptomatic pulmonary arterial hypertension.Secondary objectives• To demonstrate that either dose of ACT-…

A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed with Type 1 Diabetes Mellitus.

The primary objective is to evaluate the efficacy of i) a prime-and-boost regimen with 20 µg Diamyd and ii) a prime-and-boost regimen with 20 µg Diamyd, followed by 2 additional single doses with 20 µg Diamyd, compared to placebo with respect…

A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Multicentre Study to assess efficacy and safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and Fluticasone Propionate FP)/Salmeterol Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents.

Primary: Efficacy of FF/GW642444 100/25 mcg once daily in comparison with that of FP/salmeterol 250/50 mcg twice daily during 24 weeks.Secundary: Safety and tolerability.

Doxycycline versus minocycline in the treatment of rosacea: a randomized controlled trial.

To compare the efficacy of doxycycline 40 mg (Efracea) versus minocycline 100 mg treatment in adult patients with papulopustular rosacea.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Subjects With Partial Onset Seizures, Followed by an Open-Label Extension Study

Double-Blind Study CARISEPY3013:The primary objectives of this study are to compare the efficacy safety, and tolerability of carisbamate as adjunctive treatment of partial onset seizures, relative to placebo. The secondary objectives of this study…

A double blind randomized study on the efficacy of cyclopentolate 1% and cyclopentolate 1% with tropicamide 1% in children

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…

Internet-based self-help for Insomnia: Factors that are associated with succes of the intervention

The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia.

Prediction and Prevention of Posttraumatic Stress Disorder after Road Traffic Accidents in Children and Adolescents
Coping with Traumatic Events in Children and Adolescents

The objective is to investigate wether a brief CBT with parental involvement among children and adolescents with ASD reduces the risk of PTSD compared to a waitlist control group.

Franciscus Rheumatoid Arhtritis and Cardiovascular Intervention Study

The primary aim of this study is to investigate if a tight multiple cardiovascular risk reduction program is effective in reducing progression of Intima media thickness progression (subclinical atherosclerosis) in patients with RA compared to usual…

A randomized, controlled extension study of CACZ885H2357 on the treatment and prevention of gout flares in patients with frequent flares and for whom NSAIDs and/or colchicines are contraindicated, not tolerated or ineffective (CACZ885H2357E1)

Primary: Longterm safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.

A phase III multicenter, randomized, parallel, controlled, double blind study to investigate the safety and efficacy of inhaled mannitol over 12 months in the treatment of bronchiectasis.

2.1.1 Primary Objective:To evaluate the difference in the rates of graded pulmonary exacerbations in patients with bronchiectasis treated with inhaled mannitol compared with placebo control2.1.2 Secondary Objectives:EfficacyTo evaluate the…