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NCT ID: NCT02753218 Terminated - Psoriasis Vulgaris Clinical Trials

A Phase I Study With LEO 32731 and Midazolam in Healthy Male Subjects

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

The purpose of this study is to investigate the effects of multiple oral doses of LEO 32731 on the pharmacokinetics of a single oral dose of the cytochrome P450 3A substrate midazolam in healthy male subjects.

NCT ID: NCT02749435 Terminated - Clinical trials for Type II Diabetes Mellitus

A Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus

Start date: May 3, 2016
Phase: N/A
Study type: Observational

A real-world, point-of-care, randomized, parallel group, open, 6-month clinical study to evaluate if the provision of a digital disease management tool improves glycaemic control in participants with type 2 diabetes mellitus (T2DM), as measured by change from baseline to End of Study (Month 6) in glycosylated haemoglobin (HbA1c) levels. Clinical assessments for this study will be conducted as part of normal, standard care. The main objective of this study is to evaluate the effect of adding this tool to participants' current standard care for T2DM on glycaemic control, other variables of importance in T2DM (eg, weight, blood pressure, and lipid levels), and participant-reported outcomes (PROs), such as satisfaction with treatment and adherence to their antihyperglycaemic treatment

NCT ID: NCT02749071 Terminated - Clinical trials for Gastroesophageal Reflux

An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux

Start date: May 2016
Phase: N/A
Study type: Interventional

The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled study. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for six months followed by an additional open-label phase in which all subjects will receive electrical stimulation. Subjects continue on stimulation treatment in an extended open-label follow-up phase through 5 years post-stimulation.

NCT ID: NCT02745145 Terminated - Clinical trials for Systemic Sclerosis-associated Interstitial Lung Disease

Abituzumab in SSc-ILD

Start date: May 31, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this trial was to compare two doses of abituzumab with placebo and determine whether abituzumab was more effective, safer, would be better tolerated and could provoke better immune response than placebo in the treatment of participants with SSc-ILD who already receive constant doses of mycophenolate.

NCT ID: NCT02745119 Terminated - Geographic Atrophy Clinical Trials

Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)

Start date: July 21, 2016
Phase: Phase 3
Study type: Interventional

This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.

NCT ID: NCT02744820 Terminated - Healthy Clinical Trials

Multiple Ascending Dose Study of GMC-252-L-Lys Salt in Healthy Subjects and Type 2 Diabetics

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

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of multiple oral doses of GMC-252-L-Lysine salt (GMC-252) in healthy subjects and type 2 diabetics. The secondary objective is to explore the effect of multiple oral doses of GMC-252 on pharmacodynamic(PD) parameters in type 2 diabetics.

NCT ID: NCT02742519 Terminated - Cystic Fibrosis Clinical Trials

A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation

Start date: May 2016
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (LCI), in subjects with cystic fibrosis (CF) who have a specified CF transmembrane conductance regulator (CFTR) gating mutation

NCT ID: NCT02736188 Terminated - GNE Myopathy Clinical Trials

Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace-ER) Tablets in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)

Start date: May 2, 2016
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the long-term safety and efficacy of Ace-ER treatment in subjects with GNEM.

NCT ID: NCT02732925 Terminated - Multiple Myeloma Clinical Trials

To Compare Conservative Management Vs. Balloon Kyphoplasty in the Treatment of VCFs in Patients With Multiple Myeloma

MELODY
Start date: June 9, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether surgical treatment, balloon kyphoplasty is more effective compared to conservative treatment alone (sham procedure) when assessing clinical, translational, radiological & patient outcomes in patients with multiple myeloma. Subjects will be recruited to the study if they have VAS score ≥ 6 and has given informed consent to participate in the Melody Study will be randomised to Arm 1 Sham Procedure and Conservative treatment or Arm 2 Balloon Kyphoplasty and Conservative treatment. Subjects recruited to Arm 1 (Sham Procedure and Conservative treatment) can cross over into Arm 2 (Balloon Kyphoplasty and Conservative Treatment) if they have a VAS score ≥ 6 between 8-12 weeks.

NCT ID: NCT02725372 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH

INOvation-1
Start date: April 2016
Phase: Phase 3
Study type: Interventional

Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2