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A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis

The primary objective of this study is to assess whether the efficacy of ocrelizumab given as two dose regimens of 600 mg (given as 300 mg infusions on days 1 and 15 and 600 mg infusion in the following cycles) or 400 mg (given as 200 mg infusions…

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn*s Disease

The primary objectives are:- To evaluate clinical remission for the 2 subcutaneous (SC) maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn*s disease induced into clinical response with ustekinumab in the…

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn*s Disease

The primary objectives are:- To evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn*s disease.- To evaluate the safety of IV induction regimens of…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With optional Open-label Extension

Part 1:The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS. The secondary objectives of this study are to determine in this study…

Early Beta blocker Administration before reperfusion in patients with ST-Elevation Myocardial Infarction who are planned to undergo primary PCI

The primary objective of this randomized trial is to assess the beneficial effects of early administration of 5 mg Metoprolol intravenously before reperfusion on infarct size in patients with ST elevation myocardial infarction who are planned to…

A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 plus CVP vs. MabThera® plus Cyclophosphamide,
Vincristine, Prednisone vs. MabThera® plus Cyclophosphamide, Vincristine, Prednisone, followed by GP2013 or MabThera® Maintenance Therapy in Patients with Previously Untreated, Advanced Stage Follicular Lymphoma

*To demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-CVP combination treatment to patients who receive MabThera®-CVP treatment. ORR will be determined during the combination treatment…

Dexamethasone for the prevention of a pain flare after palliative radiotherapy for painful bone metastases: a multicenter double-blind placebo-controlled randomized study.

Aim of the studyTo study the effectiveness and toxicity of dexamethasone to prevent the occurrence of a pain flare after short schedule radiotherapy for painful bone metastases and to define the optimal schedule of dosing.Research questions:1. What…

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Patients

The purpose of this current study is to evaluate the efficacy and safety of the 3-day oral aprepitant regimen when administered concomitantly with ondansetron, with or without dexamethasone, in pediatric patients, from 6 months to 17 years of age,…

A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)

The objective of the trial is to confirm efficacy and a favorable benefit-risk ratio for BIBF 1120 in the treatment of IPF at the dose of 150 mg bid compared to placebo.

Anamorelin HCl in the Treatment of
Non-Small Cell Lung Cancer - Cachexia (NSCLC-C):
A Randomized, Double-Blind, Placebo-Controlled,
Multicenter, Phase III Study to Evaluate the
Safety and Efficacy of Anamorelin HCl
in Patients with NSCLC-C

Based on the data available, Anamorelin HCl produces an increase in total body weight and Lean Body Mass in patients with advanced cancer, and specifically in patients with NSCLC, in addition to increasing muscle strength and improving quality of…

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura).

Core Study:Primary objective: • To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic…

A Phase III, Double-Blind, Placebo Controlled, Parallel Group, International, Multicenter Study of 12 Weeks Treatment with Trafermin 0.01% Spray in Patients with Diabetic Foot Ulcer of Neuropathic Origin.

Trafermin spray is a new treatment that is being studied in wound healing and particularly for the treatment of diabetic foot ulcers. When trafermin is sprayed onto a wound, it stimulates the skin and blood vessels to grow again and so speeds up the…

A multi-center, randomized, double-blind, placebo-controlled clinical trial of deferasirox in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload (TELESTO)

Use of iron chelation therapy has demonstrated benefits in terms of morbidity and mortality for chronically-transfused thalassemia patients with iron overload. Recent retrospective data (Leitch 2007, Rose 2010, Sanz 2008) suggest that overall…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy

The primary objectives are:- To evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn*s disease who have failed or are intolerant to one or more tumor…

A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double
Dummy Extension Study of Preladenant in Subjects With Moderate
to Severe Parkinson*s Disease

This is a active-controlled dose-range-finding study which is also designed to assess the efficacy and safety of preladenant 2, 5, 10 mg twice daily during long term use as an adjunct therapy to L-dopa when administered to subjects with moderate to…

A double blind randomized placebo controlled study on the efficacy of intralymphatic immunotherapy in the treatment of grasspollen induced allergic rhinitis.

In this study we will compare the effect of intra nodal allegen injection with grass pollen to the intra nodal injection with placebo on symptome scores of allgic rhinitis (hay fever) in grass allergic patients.

Effect of C1-esterase inhibitor on systemic inflammation in trauma patients with a femur or pelvic fracture.

A previous study of from our laboratory showed that administration of the drug C1-INH (100E/kg) significantly reduced the concentration of circulating pro-inflammatory cytokines, such as IL-6, in healthy male volunteers during human experimental…

An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescents.

The primary objective of the METFORMIN study is to determine the efficacy of metformin in combination with lifestyle-intervention in obese children and adolescents with insulin resistance versus placebo with lifestyle-intervention. The secondary…

Phase III Randomized Double-blind Cross-over trial of Supersaturated Calcium-phosphate rinse (Caphosol®) versus NaCl 0.9% in the relief of Oral Mucositis in patients receiving Targeted Therapy

To assess the effect of Caphosol® oral rinse on clinical outcomes of selected oral symptom burden (oral mucositis/stomatitis (aphthous-like), oral pain, taste change (dysgeusia), difficulty swallowing (dysphagia), difficulty oral intake, and dry…

A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES

The primary objective of this study is to evaluate the efficacy of 2 dose levels of pregabalin (Level 1: 2.5 mg/kg/day; maximum 150 mg day and Level 2: 10 mg/kg/day; maximum 600 mg day) compared to placebo as an adjunctive treatment in reducing the…