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A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) (BEL114055)

Primary: safety and tolerability of belimumab in a pediatric population (5-17 y) with SLE.Secondary: PK, efficacy, quality of life.

A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, Compared with Placebo in Combination with Docetaxel, in Patients receiving second line treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB-IV)

To assess the efficacy, measured as progression free survival, and safety of Selumetinib in combination with docetaxel, compared to docetaxel alone, in patients receiving second line treatment for KRAS mutation negative locally advanced or…

Proof-of-concept double-blind, placebo-controlled, randomized clinical trial with nilotinib in spondyloarthritis

To evaluate the efficacy and safety of nilotinib in spondyloarthritis

A Phase 2 Efficacy and Safety Study of LY2484595 Alone and in Combination with Atorvastatin, Simvastatin, and Rosuvastatin in Patients with Hypercholesterolemia or Low HDL-C.

The primary objective of this study is to determine whether LY2484595, administered incombination with atorvastatin for 12 weeks to patients with hypercholesterolemia or low HDL-C, will significantly increase mean HDL-C and decrease mean LDL-C from…

Single-Center, Randomized Single-Blind Placebo-Controlled Five-Arm Parallel Group Study to Assess Efficacy of a Single Dose of TBS-2 Intranasal Gel at Four Time Points Post-Dose using Vibrotactile Stimulation combined with Visual Sexual Stimulation in Female Subjects with Primary and Secondary Anorgasmia

This clinical trial is being performed to evaluate the efficacy of a single dose of TBS-2 on the occurence of orgasm. This study will explore the effect of TBS-2 on inducing an orgasm following sexual stimuli in anorgasmic female subjects at four…

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS)

The purpose of this study is to determine if SAR153191 SC (subcutaneous) injection once a week or every other week is safe and effective compared to placebo (an inactive solution injection ) in reducing the recurrence and symptoms of Ankylosing…

A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers

The primary aim of the study is to determine the effect of orally administered AZD2516 as a reduction of the number of reflux episodes, in comparison with placebo, over a period of approximately three hours after a meal, in healthy male volunteers.

Efficacy of agomelatine 25 mg/day (with possible increase to 50 mg/day after 8 weeks of treatment) given orally during 16 weeks in patients with Obsessive-Compulsive Disorder.A randomised, double-blind, placebo-controlled, parallel groups, international study.

The primary objective of the study is to evaluate the efficacy of agomelatine (25-50 mg/day) compared to placebo on the reduction of Obsessive and Compulsive symptoms by using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) after 16 weeks of…

A Phase II/III Study of MK-0646 Treatment in Combination with Cetuximab and
Irinotecan for Patients with Metastatic Colorectal Cancer

There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS

The primary objective is to characterize the change in the Pharmacodynamic (PD) biomarker, fecal calprotectin, during treatment with anrukinzumab.The secondary objectives include:* Characterization of the PK profile and total IL-13 of three multiple…

A randomized, single-blind, placebo controlled, parallel-group study evaluating the anti-inflamatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis (OSM105196)

Primary ObjectivesTo assess the change in inflammatory biomarkers in the synovial tissue of subjects with RA on a background of methotrexate after administration of a single, intravenous dose of GSK315234, as compared to placebo. To assess the…

A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary Fibrosis

The primary objective is to determine the efficacy (as measured by pulmonaryfunction) and safety of CNTO 888 in subjects with IPF. The major secondary objectives are to assess theeffect of CNTO 888 on measures of disease progression, to assess the…

A Multicenter, Randomized, Double-blind, Placebocontrolled, Parallel-group, Phase 2a Study of Oral IW-9179 Administered Once Daily for 14 Days to Patients with Functional Dyspepsia

The objectives of this study are to determine the safety and efficacy of IW-9179administered to patients with functional dyspepsia (FD), with and without concomitant protonpump inhibitor (PPI) administration.

Safety and efficacy of TRC4186 in the treatment of stable heart failure associated with HbA1c >= 6.5 % or type 2 diabetes receiving oral hypoglycaemic therapy (with or without additional insulin) as an add-on to conventional treatment for heart failure

The objectives are to evaluate the safety and efficacy of TRC4186 and to define the recommended dose level for further pivotal studies.

Does helium protect the heart against ischaemia-reperfusion damage in patients with acute myocardial infarction?

To investigate whether the inhalation of helium during rpimary PCI can reduces the size of myocardial infarction.

A randomized, double-blind, placebo-controlled, phase 2 study to evaluate the safety and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to methotrexate therapy.

The primary objective of the study is to evaluate the safety and tolerability of CCX354-C in subjects with rheumatoid arthritis (RA) who had an inadequate response to methotrexate treatment.The secondary objectives of the study are to evaluate the…

Pharmacological enhancement of fear extinction in OCD; a randomized placebo controlled, double blind study.

treatment outcome in OCD. Objective: The objective for this study is fourfold. First we will determine whether DCS addition to behavioural exposure therapy may enhance fear extinction and improve symptoms in OCD. Our hypothesis is that improvement…

Body Dysmorphic Disorder: Pharmacological enhancement of fear extinction; a randomized placebo controlled, double blind study.

The objective for this study is threefold. First we will determine whether DCS addition to behavioural exposure therapy may enhance fear extinction and improve symptoms in BDD. Our hypothesis is that improvement will occur and at a faster rate than…

The effect of inhaled heparin on pulmonary coagulation activation and vascular permeability in mechanically ventilated patients with acute lung injury / acute respiratory disress syndrome

Objectives1. to determine whether nebulization of heparin decreases coagulation activation in the pulmonary compartment (i.e. BAL fluid)2. to determine whether nebulization of heparin decreases pulmonary vascular permeability

A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy

Primary Objective* To assess the safety, tolerability, and efficacy (in terms of change in DAS28 [using C-ReactiveProtein (CRP)] from baseline) of JNJ-38518168 at a dose of 100 mg/day for up to 12 weekscompared to placebo in subjects with active…