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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 (…

Erythrocytapheresis versus Phlebotomy as maintenance therapy in patients with hereditairy hemochromatosis; a randomised, single blinded, sequential, cross-over trial

The primary objective of the study is to determine the gain in effectiveness of TE compared with P when applied to remove excess iron during maintenance therapy of HH patients.

A Phase 1/2, Ascending Multiple-Dose Study to Evaluate the Safety, Efficacy and Pharmacokinetics of BMS-753493 in Subject with Advanced Cancer

To determine the maximum tolerated dose, dose limiting toxicity and recommended Phase 2 dose of BMS-753493 in subjects with advanced cancer.

The effect of a mixture of probiotics on constipation symptoms in pregnant women

Hypotheses1) The use of a combination of probiotic strains results in a significant increase in defecation frequency in pregnant women with constipation.2) The use of a combination of probiotic strains results in less episodes of difficult…

A Phase III, randomised, parallel group, double-blind, double-dummy, active comparator -controlled, multi-center study to assess the efficacy and safety of PGL4001 (ulipristal) versus GnRH-agonist (leuprorelin 3.75mg) for pre-operative treatment of symptomatic uterine myomas.

Efficacy Objectives:- Primary objective of this study is to demonstrate non inferior efficacy of PGL4001 versus GnRH-agonist to reduce, prior to surgery, excessive uterine bleeding caused by uterine myomas.- Secondary objectives are to demonstrate…

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.

An Open-Label Study to Investigate the Pharmacokinetics (Distribution, Metabolism, and Excretion) of Bendamustine Hydrochloride Following Intravenous Infusion of [14C]Bendamustine Hydrochloride in Patients With Relapsed or Refractory Malignancy (Hematologic or Nonhematologic)

The primary objective of the study is to quantitatively determine the pharmacokinetics (distribution, metabolism, and excretion) of [14C]bendamustine and its metabolites in patients with confirmed, relapsed or refractory malignancy (hematologic or…

Improvement of ischemia and myocardial blood flow in patients with ischemic cardiomyopathy after treatment with Electric Shock Wave Therapy using CMR

Primary Objective: Improvement in myocardial blood flow and reverse remodelingSecondary Objective(s): Improvement in wall motion abnormalities, left ventricular function and NYHA class

A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course.

Primary Objective: • The primary objective of the study is to evaluate the efficacy of three doses of atacicept to reduce CNS inflammation in subjects with RMS as assessed by frequent MRI.Secondary Objectives: • Evaluate safety and tolerability of…

Select Stim: Selective stimulation of the subthalamic nucleus in Parkinson*s disease
"A feasability study"

The primary objective is to avoid cognitive and affective side effects and maintain the beneficial motor effects by selective stimulation of the STN motor part. With the Select Stim project we want to improve the classical operation procedure, in…

Effect of dietary proteins on blood pressure

The primary objective of the study is to demonstrate a difference in changes in fasting blood pressure and 24-hour ambulatory blood pressure after 4 weeks on a diet with a high protein content or a diet with a high carbohydrate content.Secondary…

Phase I study: determining toxicity and immunity of the p53 synthetic long peptides vaccine combined with Interferon-alfa in patients treated for colorectal cancer

Primary objectives of the study are to assess whether the administration of p53-SLP together with the local administration of IFNα is safe and able to induce a strong (directly ex-vivo detectable) p53-specific CD4+ T-cell response. Secondary…

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…

Anti-VEGF (bevacizumab/ranibizumab) versus RPE-choroid graft in the treatment of 1) non-responders to 3 intravitreal anti-VEGF injections, or 2) patients with AMD and pigment epithelium rip, or 3) patients with AMD and massive haemorrhage. A randomized trial.

To compare visual outcome and foveal function after (initiation of) treatment between patients receiving an RPE-choroid graft and patients with anti-VEGF medication.

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm,
Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab
(MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in
Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

Primary:The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, andsafety of teplizumab when administered according to 3 different teplizumab dosing regimens insubjects with recent-onset (onset within past…

A PHASE I, SINGLE-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, SINGLE- AND MULTIPLE ASCENDING-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF GRC 10693 IN HEALTHY MALE SUBJECTS

The study has three objectives. Firstly, we will study the safety and tolerability of the drug after the administration of both single and multiple doses of the drug. Secondly, we will study the speed at which the drug is absorbed in the body, as…

A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis

In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on: Primary: - Alkaline phosphatase (AP) levels - SafetySecondary: - Hepatocellular injury and liver function - Disease-specific and general health…

A RANDOMIZED PHASE II STUDY OF CONCOMITANT TRASTUZUMAB, BEVACIZUMAB WITH PACLITAXEL VERSUS TRASTUZUMAB AND BEVACIZUMAB FOLLOWED BY THE COMBINATION OF TRASTUZUMAB, BEVACIZUMAB AND PACLITAXEL AT PROGRESSION AS FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER WITH HER2-NEU OVEREXPRESSION

Primary objective: To establish whether concomitant therapy of trastuzumab, bevacizumab with paclitaxel (regimen A) and/or trastuzumab and bevacizumab followed by the combination of trastuzumab, bevacizumab, and paclitaxel at progression (regimen B…

A MULTI-CENTRE, PROSPECTIVE, POST MARKETING SURVEILLANCE STUDY INVESTIGATING THE PERFORMANCE OF CERVICAL ARTHROPLASTY FOR THE TREATMENT OF CERVICAL DEGENERATIVE DISC DISEASE (DDD)

The primary objective of this investigation is to evaluate the performance of the DISCOVER Artificial Cervical Disc in the treatment of cervical disc disease by measuring the function assessed via Neck Disability Index (NDI) and neurological…