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NCT ID: NCT03099096 Completed - Asthma Clinical Trials

Study of Mepolizumab Autoinjector in Asthmatics

Start date: May 4, 2017
Phase: Phase 3
Study type: Interventional

This study is aimed to assess the correct real-world use of an autoinjector for the repeat self-administration of mepolizumab SC, so to improve subject / physician convenience and to enable repeat dose self injection themselves or via caregivers. This Phase III study will be an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in autoinjector (100 milligrams [mg]) administered subcutaneously (SC) every 4 weeks (3 doses) in subjects with severe eosinophilic asthma. Subjects will receive 100 mg mepolizumab SC as a single injection that is self-administered in the thigh, abdomen or administered in the upper arm (caregiver only). Each subject will participate in the study for up to 18 weeks including pre-screening visit, a screening visit and a 12-week treatment period which concludes with end of study assessments (Visit 5) 4 weeks after the last dose of mepolizumab. Approximately 158 subjects will be enrolled in the study.

NCT ID: NCT03098030 Completed - Clinical trials for Small Cell Lung Cancer

Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer

Start date: June 1, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period <3 months or ≥3 months).

NCT ID: NCT03095521 Completed - Sore Throat Clinical Trials

A Local Clinical Study for the Comparative Evaluation of Efficacy and Safety of Angal, Lozenges [Menthol] and ANTI-ANGIN® FORMULA, Lozenges, in Treatment of Patients With a Sore Throat

Start date: February 22, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate no less therapeutic efficacy and safety of the Angal, lozenges [Menthol], 1 mg + 5 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, lozenges, 0,2 mg + 2 mg + 50 mg (LLC "Valeant", Russia) in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat.

NCT ID: NCT03095508 Completed - Sore Throat Clinical Trials

Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat

Start date: February 22, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate no less therapeutic efficacy and safety of the Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN® FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC "Valeant", Russia) in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat.

NCT ID: NCT03091166 Completed - Clinical trials for Patient Outcome Assessment

Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients

Start date: December 2016
Phase: Phase 4
Study type: Interventional

Investigation of effect of perioperative Dexmedetomedine administration on mortality, length of ICU and hospital stay, delirium onset, major adverse cardiac and cerebrovascular events, acute kidney injury in cardiac surgery patients.

NCT ID: NCT03090139 Completed - Crohn Disease Clinical Trials

Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets

Start date: March 28, 2017
Phase:
Study type: Observational

The purpose of this study is to establish the incidence of sub-optimal response to anti-TNF therapy in UC and CD participants.

NCT ID: NCT03089944 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

EXPEDITION-8
Start date: April 28, 2017
Phase: Phase 3
Study type: Interventional

A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.

NCT ID: NCT03088813 Completed - Clinical trials for Small Cell Lung Cancer

Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer

RESILIENT
Start date: April 25, 2018
Phase: Phase 3
Study type: Interventional

A randomized, open label phase 3 study of irinotecan liposome injection (ONIVYDE®) versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy The study was conducted in two parts: 1. Dose determination of irinotecan liposome injection 2. A randomized, efficacy study of irinotecan liposome injection versus topotecan

NCT ID: NCT03088670 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Gosogliptin as Monotherapy and in Combination With Metformin vs. Vildagliptin as Monotherapy and in Combination With Metformin in Drug-naive Type 2 Diabetic Patients.

Start date: April 23, 2013
Phase: Phase 3
Study type: Interventional

To demonstrate that efficacy of Gosogliptin as Monotherapy and in Combination with Metformin is non-inferior to efficacy of Vildagliptin as Monotherapy and in combination with Metformin in the effects on glycosilated hemoglobin (HbA1c) at Week 12 and Week 36 compared to baseline (Week 0).

NCT ID: NCT03088358 Completed - Clinical trials for Total Knee Replacement

Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement

Start date: August 2013
Phase: Phase 2
Study type: Interventional

To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group: - Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality - Incidence of DVT (total, proximal, distal) - Incidence of nonfatal PE - Incidence of symptomatic VTE (DVT, PE) - VTE caused mortality - Non-VTE caused mortality - Incidence of all hemorrhagic complications - Incidence of major and clinically relevant non-major bleeding - Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results