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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…

Boosting Oxytocin after trauma: Neurobiology and the Development of Stress-related symptoms.

Primary aim:In recently traumatized individuals (at the latest on day ten post trauma exposure) with a high initial level of distress, we aim to assess the effectiveness of intranasal OT in preventing symptoms of PTSD at one months post intervention…

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…

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…

Effect of infrapatellar nerve block on chronic anterior knee pain after tibial nailing.

To study the effect of a nerve block of the infrapatellar nerve with local infiltration with lidocaine or saline on chronic anterior knee pain after tibial nailing.Secondairy objectives:- to measure knee pain on a VAS for eight different activities…

Dexamethasone in community-acquired pneumonia.

Primary Objective: - To confirm the effect of dexamethasone on clinical outcome in patients admitted with CAP.Secondary Objectives: - To study what patients admitted with CAP benefit most from dexamethasone therapy. Predefined subgroup analysis…

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…

Interventional, randomised, double-blind, sequential-group, placebo-controlled single ascending dose study investigating the safety, tolerability, and pharmacokinetic properties of Lu AF34134 in healthy young men and healthy elderly men and women, and open-label, three-period crossover, food interaction study of Lu AF34134 in healthy elderly men and women.

- to examine the safety and tolerability of the research medication- to examine how the research medication is absorbed, broken down and excreted by the body.

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 multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the renal hemodynamic effects of RLX030 at a dose of 30 µg/kg/day or placebo infused for 24 hours in subjects with chronic heart failure (CHF).

Primary objective(s)To assess the effects of 24 hrs i.v. infusion of RLX030 30µg/kg/day compared to placebo on renal blood flow (RBF) as measured by PAH clearance in subjects with CHF and worsening symptoms To assess the effects of 24 hrs i.v.…

A Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Effect of CCX140-B on Albuminuria in Subjects with Type 2 Diabetes Mellitus

The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment on urinary albumin excretion in subjects with type 2 diabetes mellitus (T2DM) with albuminuria.The primary safety objective of this study is to evaluate the…

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 Phase 3 clinical study to determine the pharmacokinetics, safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding episodes in subjects diagnosed with von Willebrand disease

Primary objective:• Assess the pharmacokinetics (PK) of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary VWDSecundary objectives:• Compare 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…

The impact of timed protein supplementation to maximize the skeletal muscle adaptive response to resistance type exercise training in healthy young men

The primary objective of this study is to examine the beneficial effects of nutritional support on the resistance type exercise training-induced changes in body composition and muscle fiber characteristics in healthy young men.

A Phase 2, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of IPI-926 in Patients with Metastatic or Locally Advanced (Unresectable) Chondrosarcoma

The primary objectives are to:• Compare progression-free survival (PFS) in patients with metastatic or locally advanced (unresectable) chondrosarcoma administered IPI-926 or placebo.• Evaluate the safety of IPI-926 in patients with metastatic or…