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NCT ID: NCT02564094 Completed - Anemia Clinical Trials

A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies

Start date: February 2005
Phase: Phase 4
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals.

NCT ID: NCT02563106 Completed - Clinical trials for Clostridium Difficile

A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI

Start date: October 2015
Phase: Phase 2
Study type: Interventional

A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract Infection (LRTI).

NCT ID: NCT02561091 Completed - Hearing Loss Clinical Trials

AM-111 in the Treatment of Acute Inner Ear Hearing Loss

HEALOS
Start date: November 2015
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to test the effectiveness and safety of the study drug, AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the cause is unknown.

NCT ID: NCT02561039 Completed - Clinical trials for Pain; Bone Neoplasms; Neoplasm Metastasis

A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease

Start date: December 2006
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky Performance Index (KPI) will be measured at intervals throughout the study. The anticipated time on study treatment is 4 months and the target sample size is 150 individuals.

NCT ID: NCT02559310 Completed - Clinical trials for Community Acquired Pneumonia

Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia

LEAP
Start date: September 2015
Phase: Phase 3
Study type: Interventional

This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia.

NCT ID: NCT02557035 Completed - Clinical trials for Chemotherapy-Induced Nausea and Vomiting

An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting

Start date: October 2015
Phase: Phase 3
Study type: Interventional

PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron 0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered as a 30-second IV bolus (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that infused IV palonosetron 0.25 mg is as effective as (non-inferior to) injected palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic chemotherapy

NCT ID: NCT02555878 Completed - Neoplasms Clinical Trials

A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants

Start date: September 11, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.

NCT ID: NCT02555215 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

Start date: February 22, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS) outcomes in subjects who completed Study 109MS202 (NCT02410200).

NCT ID: NCT02554786 Completed - Asthma Clinical Trials

A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma

Start date: December 29, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants as determined by pulmonary function testing, and effects on asthma control

NCT ID: NCT02554773 Completed - Hemophilia A Clinical Trials

An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or B

Start date: September 18, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objective: To evaluate the long-term safety and tolerability of fitusiran in male patients with moderate or severe hemophilia A or B Secondary Objectives: - To investigate the long-term efficacy of fitusiran - To characterize the safety and efficacy of concomitantly administered Factor VIII (FVIII), Factor IX (FIX) or bypassing agents (BPA) and fitusiran for treatment of bleeding episodes - To assess changes in health-related quality of life (QOL) over time - To characterize antithrombin (AT) reduction and thrombin generation (TG) increase - To characterize the pharmacokinetics (PK) of fitusiran