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A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases

Primary: The primary objective of the Double-blind Acute Phase of the study is to assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate UC.The primary…

A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced bronchoconstriction in patients with stable, mild to moderate asthma

Primairy Objective: To demonstrate therapeutic equivalence between Bricanyl Turbuhaler M3 and Bricanyl Turbuhaler M2 using bronchoprotective effect as outcome measure. Secondary Objective: To compare safety of Bricanyl Turbuhaler M2 and Bricanyl…

A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the
efficacy and safety of lenalidomide (Revlimid®) as maintenance therapy for high-risk patients with
chronic lymphocytic leukemia following first-line therapy

To compare the efficacy and safety of lenalidomide versus placebo maintenance therapy (standard care).

A Phase 3 Extension, Multicenter, Double-blind, Parallel-Group, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer Disease Who Are Apolipoprotein E E4 Noncarriers and Participated in Study 3133K1-3000-WW

Primary objectives: To evaluate the long-term safety and tolerability of IV administered bapineuzumab in subjects with AD.Secundary objectives: Efficacy. To explore the long-term efficacy of IV administered bapineuzumab in subjects with AD, using…

A Randomised, Double-blind, Active Treatment Study to Induce
Clinical Response and/or Remission with GSK1605786A in
Subjects with Moderately-to-Severely Active Crohn*s Disease

Primary Objective:To induce clinical response (CDAI decrease from baseline * 100 points) and/or remission(CDAI <150) following 12 weeks of treatment with one of two active doses ofGSK1605786A for qualification of subjects for enrolment into a…

Effect of Prucalopride on Gastroesophageal Reflux, Esophageal Motility and Gastric Emptying in healthy volunteers

To asses the effect of Prucalopride on esophageal contraction characteristics and lower esophageal sphincter pressure, gastric emptying and esophageal reflux parameters in healthy male subjects

A prospective double-blind randomized Phase III study of 300 mg vs. 150 mg erlotinib in current smokers with locally advanced or metastatic NSCLC in second-line setting after failure on chemotherapy

To compare the efficacy of two dose levels of erlotinib (150 mg and 300 mg) on progression-free survival (PFS) in current smokers with stage IIIB/IV NSCLC after failure of first-line platinum-based chemotherapy.

Effect of Olmesartan Medoxomil on arterial stiffness and thickness in subjects with metabolic syndrome.

to investigate in a descriptive way the dose-dependent effect of Olmesartan Medoxomil 20mg, 40mg en 80mg on arterial stiffness.

Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses

To document the long-term safety and tolerability of teriflunomide in MS patients with relapses.

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 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…

Innovative approaches for cocaine pharmacotherapy using fMRI: The case of varenicline

Drug craving and impulsivity will be assessed with questionnaires, fMRI/EEG using cue-reactivity and impulsivity paradigms. Relapse will be assessed by checking urine samples every week.

Innovative approaches for cocaine pharmacotherapy using fMRI and SPECT: The case of rimonabant

Striatal D2 receptor availability will be ascertained in 30 recent abstinent cocaine addicts by [123I]IBZM SPECT. In addition, we will measure drug craving and impulsivity with questionnaires, fMRI/EEG using cue-reactivity and impulsivity paradigms…

A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) Compared to Immediate Release Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy

Primary: To demonstrate the superior efficacy of Nasalfent in the treatment of BTCP in opioid tolerant subjects who are receiving regular opioid therapy.Secondary: To demonstrate the safety, tolerability, and acceptability of Nasalfent in the…

A randomized, double-blind trial comparing the efficacy and safety of a fixed combination of fenofibrate and metformin vs rosiglitazone in patients with type 2 diabetes mellitus and dyslipidemia

Primary objective : Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients (no antidiabetic drug treatment in the last 6 months), with type 2 diabetes mellitus and dyslipidemia, to show that : - the efficacy of a…

A randomized long-term safety study of Org 50081 in elderly outpatients with chronic primary insomnia examining the effects of 1.5 mg or 3.0 mg of Org 50081

Primary • To investigate the safety and tolerability of long-term treatment with 1.5 mg or 3.0 mg of Org 50081 in elderly outpatients with chronic primary insomnia. Secondary • To collect exploratory efficacy data of long-term treatment with Org…

A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn*s Disease

The purpose of this study is to evaluate the safety and effectiveness of adalimumab for the treatment of moderate to severe Crohn*s disease in children between 6-17 years of age. In addition, information will be collected to select the most…

A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, and GT6 Infection who are on Opiate Substitution Therapy.

3.1 Primary Objective(s): 1) Objective: To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as…

BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age

To evaluate the safety and efficacy of BOTOX for the treatment of urinary incontinencedue to overactive bladder (OAB) in patients 12 to 17 years of age who have not been adequately managed with anticholinergic therapy. To evaluate the safety and…

A 26- week Extension study of the safety and clinical effects of EVP-6124 in subjects with Alzheimer's disease currently or previously receiving an acetylcholinesterase inhibitor medication

Primary ObjectivesTo assess the safety of 2 fixed doses of EVP-6124 (2 or 3 mg daily) for up to 52 weeks in subjects withAlzheimer*s disease (AD) who complete (Day 182) studies EVP-6124-024 or EVP-6124-025Secondary ObjectivesTo assess the duration…