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NCT ID: NCT01345929 Completed - Pyelonephritis Clinical Trials

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

Start date: June 20, 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis).

NCT ID: NCT01345799 Completed - Crohn's Disease Clinical Trials

A Study of TRK-170 for the Treatment of Crohn's Disease

Start date: April 2011
Phase: Phase 2
Study type: Interventional

In Crohn's Disease Patients - To evaluate the efficacy of TRK-170 - To evaluate the PK characteristics of TRK-170 - To assess the safety of TRK-170

NCT ID: NCT01344954 Completed - Clinical trials for Prophylaxis of Venous Thromboembolic Events

Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery

Start date: April 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.

NCT ID: NCT01339559 Completed - Epilepsy Clinical Trials

Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy

BRITEā„¢
Start date: May 11, 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).

NCT ID: NCT01337089 Completed - Pain Clinical Trials

Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain

Start date: January 19, 2011
Phase: Phase 3
Study type: Interventional

This was a six-month open-label extension (OLE) study to evaluate the safety of long-term nabiximols (Sativex®) therapy when used as an adjunctive treatment in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding Phase 3 study and new (de novo) participants.

NCT ID: NCT01332019 Completed - Clinical trials for Relapsing Multiple Sclerosis

Long-Term Safety and Efficacy Study of Peginterferon Beta-1a

ATTAIN
Start date: April 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this study is to describe long-term multiple sclerosis (MS) outcomes in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.

NCT ID: NCT01331837 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors

Start date: August 2011
Phase: Phase 4
Study type: Interventional

This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg) etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug (DMARD).

NCT ID: NCT01328951 Completed - Clinical trials for Non-Squamous Non-Small Cell Lung Cancer

A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy

Start date: September 2011
Phase: Phase 3
Study type: Interventional

This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will continue until disease progression, death, or unacceptable toxicity. Participants may also be entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.

NCT ID: NCT01327846 Completed - Atherosclerosis Clinical Trials

Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)

CANTOS
Start date: April 11, 2011
Phase: Phase 3
Study type: Interventional

Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events. The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase. Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study was to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS). Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study was to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care could increase insulin secretion and insulin sensitivity.

NCT ID: NCT01324128 Completed - Clinical trials for Chronic Kidney Disease Requiring Chronic Dialysis

A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients

Start date: March 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.