Clinical Trials Logo

Filter by:
NCT ID: NCT02740049 Completed - Asthma Clinical Trials

In Vitro Evaluation of a Novel Drug on Airway Epithelial Cells Obtained From Participants With Severe Asthma

Start date: January 27, 2016
Phase: Early Phase 1
Study type: Interventional

Asthma is a long term disease of the lungs. In asthma patients the sensitive airway tubes narrow in reaction to something that irritates the airways such as allergens or environmental pollutants. There is currently no cure for asthma and new medicines or combinations of medicines are needed that will be of benefit to patients particularly those with a more severe disease. Activation of certain signal molecules inside the lung cells may participate in the development of asthma and the response to allergens. Blocking these signal molecules specifically with medicines might therefore be beneficial in the treatment of asthma. In this study we want to test a new medicine that specifically targets a subset of signal molecules that are associated with the allergen response in the lung. In particular, we want to test this medicine on cells obtained from the lungs of asthma patients. Understanding the effects of this new medicine on these asthmatic lung cells will give vital information on how this new medicine works before we can test it in asthma patients.

NCT ID: NCT02739425 Completed - Breast Cancer Clinical Trials

The Efficacy of Sentimag in Detection of Sentinel Node Biopsy

SMART
Start date: September 22, 2016
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the Sentimag/Sienna+ System (Sentimag®) in clinical routine practice. On the one hand this allows evaluation of the equivalence of the two techniques. On the other hand this ensures that patients do not experience any possible disadvantages by participating. The hypothesis behind this evaluation is that Sentimag is as efficient as conventional sentinel node mapping. The programme will compare the Sentimag® with the conventional sentinel lymph node detection with radioactive tracer combined with blue dye (in centres using the combined technique) and thereby determine whether the new technique is equivalent to the standard technique for SLNB.

NCT ID: NCT02739217 Completed - Diabetes Clinical Trials

Safety and Tolerability of PBI-4050 and Its Effects on the Biomarkers in Subjects With Alström Syndrome

Start date: February 22, 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2, single-centre, single-arm, open-label study of the safety, tolerability, and effects on biomarkers of PBI-4050 in subjects with Alström syndrome for a treatment duration of 24 weeks. Subjects who complete the initial 24 weeks of treatment may continue treatment for an additional 36 or 48 weeks, provided the subject signs informed consent.

NCT ID: NCT02738840 Completed - Chronic Pain Clinical Trials

A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems

SCS MRI PMCF
Start date: October 21, 2016
Phase: N/A
Study type: Interventional

A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems.

NCT ID: NCT02738801 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Start date: March 2016
Phase: Phase 2
Study type: Interventional

A multicenter randomized, double-blind, parallel group, placebo-controlled, exploratory phase IIa study in subjects with Idiopathic Pulmonary Fibrosis (IPF) to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG1690. Male and female subjects aged 40 years or older will be screened to determine eligibility. The screening period will be up to 4 weeks. At baseline, eligible subjects will be randomized in a 3:1 ratio to GLPG1690 or matching placebo administered for 12 weeks. The subjects will visit the study center at screening, baseline, Weeks 1, 2, 4, 8 and 12 and for a follow-up visit 2 weeks after the last administration of study drug. Planned assessments: Adverse event reporting, clinical laboratory tests, vital signs, physical examination, 12-Lead-ECG, PK blood sampling, biomarker blood/bronchoalveolar lavage fluid (BALF), Spirometry, St George's respiratory questionnaire, high-resolution computed tomography (HRCT).

NCT ID: NCT02738151 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

BRIGHT
Start date: May 19, 2016
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24. Secondary Objectives: Change From Baseline in HbA1c to Week 12 To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 on: - Change in Fasting plasma glucose (FPG); - Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG profile; - Percentage of participants reaching HbA1c targets <7% or ≤6.5%; - Percentage of participants reaching HbA1c targets <7% or ≤6.5% without severe and/or confirmed hypoglycemia - Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association (ADA) category of hypoglycemia. To assess the safety in each treatment group. To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO). Percentage of participants requiring rescue therapy.

NCT ID: NCT02737904 Completed - Multiple Sclerosis Clinical Trials

Effect of Active-Passive Trainer Cycling on Multiple Sclerosis

Start date: August 1, 2016
Phase: N/A
Study type: Interventional

This randomised controlled trial aims to explore the effectiveness of a four week programme of exercise using lower limb Active Passive trainer (APT) (MOTOmed trainer) in terms of spasticity in people with moderate to severe Multiple Sclerosis.

NCT ID: NCT02737501 Completed - Lung Cancer Clinical Trials

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants

ALTA-1L
Start date: May 26, 2016
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS).

NCT ID: NCT02737371 Completed - Clinical trials for Invasive Aspergillosis

Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects

ORALMAD
Start date: May 2016
Phase: Phase 1
Study type: Interventional

Double blind, placebo controlled, ascending multiple (10) oral dose, sequential group study. Twenty-four subjects will complete the study in 3 cohorts (Groups A to C), each group consisting of 8 subjects. Each cohort will consist of 4 male and 4 female subjects. Each subject will be dosed for 10 days and will be on study for approximately 7 weeks. Each subject will participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 15 (120 hours post the last dose). The dose will range between 2 and 10 mg/kg daily, given as either a single daily dose or as two doses divided over the 24-hour dosing period. All subjects will return for a post-study visit 8 to 10 days after the last dose of study medication. Cohorts will be dosed at least at 3 weekly intervals. There will be a review of the safety and pharmacokinetic data of each cohort prior to each dose escalation.

NCT ID: NCT02737007 Completed - Malaria, Falciparum Clinical Trials

A Microdose Study in Healthy Subjects to Describe Intravenous Pharmacokinetics of GSK3191607

Start date: April 18, 2016
Phase: Phase 1
Study type: Interventional

This is an open-label, single-centre, non-randomized study to investigate the pharmacokinetics of GSK3191607, administered as a single intravenous (IV) dose in healthy male subjects. Six subjects will be administered an IV microdose of radio-labeled [14C]-GSK3191607. The study will provide an early readout on human pharmacokinetic parameters. The results of this study will be used to estimate the potential duration of anti-parasite effect in humans, define predicted clinical oral doses, and hence inform about the compound's potential safety margin. Each subject will participate in the study for up to 8 weeks, and will have a screening visit, one treatment period, eight outpatient visits, and a follow-up visit.