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NCT ID: NCT02308111 Terminated - Clinical trials for Liver Cirrhosis, Biliary

Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

COBALT
Start date: December 26, 2014
Phase: Phase 4
Study type: Interventional

Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC participants.

NCT ID: NCT02307578 Available - Clinical trials for Lennox Gastaut Syndrome

An Extended Access Program (EAP) for Perampanel

Start date: n/a
Phase:
Study type: Expanded Access

The main objective of this EAP is to ensure that participants participating in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401 continue to have access to perampanel until such time that the appropriate formulation of perampanel becomes commercially available in the country in which they reside or until no participants remain in the EAP.

NCT ID: NCT02300766 Recruiting - Clinical trials for Infratentorial Neoplasms

Cerebellar Mutism Syndrome Study

Start date: October 2014
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to determine why up to 25% of the pediatric patients who have surgery for a tumor in the posterior fossa develops the Cerebellar Mutism Syndrome (CMS). Furthermore the purpose is to explore the clinical course and the best treatment of the syndrome.

NCT ID: NCT02296138 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.

Start date: January 13, 2015
Phase: Phase 3
Study type: Interventional

The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

NCT ID: NCT02294058 Completed - Multiple Sclerosis Clinical Trials

Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)

SUNBEAM
Start date: December 3, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).

NCT ID: NCT02282033 Completed - Bradycardia Clinical Trials

Safety and Performance Study of the Moderato System

Start date: March 2013
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce their blood pressure.

NCT ID: NCT02279966 Completed - Clinical trials for Major Depressive Disorder

Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder

Start date: October 2014
Phase: Phase 3
Study type: Interventional

To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning, attention) in working patients with major depressive disorder (MDD).

NCT ID: NCT02279524 Completed - Liver Diseases Clinical Trials

A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH

Aramchol_005
Start date: April 29, 2015
Phase: Phase 2
Study type: Interventional

This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years of age, with Non-Alcoholic Steatohepatitis (NASH) confirmed by liver biopsy performed in a period of 6 months before entering the study, with overweight or obesity and who are pre diabetic or type II diabetic. Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg tablets and placebo tablets in ratio 2:2:1. The subjects will be evaluated at study sites for 11 scheduled visits during one year (52 weeks). After completion of the study treatment period, the subjects will be followed for an additional period of 13 weeks without study medication (until visit 11 (week 65)).

NCT ID: NCT02277769 Completed - Dermatitis, Atopic Clinical Trials

Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

SOLO 2
Start date: November 30, 2014
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).

NCT ID: NCT02248493 Completed - Pain, Postoperative Clinical Trials

Intravenous Paracetamol for Postoperative Pain

IVPARACET
Start date: November 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to define if intravenous paracetamol may improve analgesia and outcome in pediatric surgical patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) postoperatively. Hypothesis: intravenous paracetamol in a dose 60 mg/kg/24 h IV, given in addition to IV ketoprofen (4,5 mg/kg/24h), improves analgesia and physical recovery in children and adolescents following surgery.