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NCT ID: NCT01262885 Completed - Clinical trials for Infections, Bacterial

A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses and Repeat Escalating Oral Doses of GSK2251052 in Healthy Adult Subjects

Start date: October 7, 2010
Phase: Phase 1
Study type: Interventional

GSK2251052 ((S)-3-(aminomethyl)-7-(3-hydroxypropoxy)-1-hydroxy-1,3-dihydro-2,1-benzoxaborole hydrochloride) is a Gram negative antibacterial compound currently in development for the treatment of hospital acquired Gram negative infection (including E. coli, K. pneumoniae, and Enterobacter spp.) This study will be conducted in two (2) parts, with single oral doses being explored in Part A (500, 1000, and 2000 mg) and repeat oral doses (1000 and 2000 mg, b.i.d.) being explored in Part B. Parts A and B will be single-blind, randomized, placebo-controlled, dose-rising studies in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of oral GSK2251052.

NCT ID: NCT01262365 Completed - Clinical trials for Systemic Lupus Erythematosus

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

EMBODY1
Start date: December 2010
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)

NCT ID: NCT01262196 Completed - Shock, Traumatic Clinical Trials

Phase IIb Study of MP4OX in Traumatic Hemorrhagic Shock Patients

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

MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid. Due to its molecular size and unique oxygen dissociation characteristics, MP4OX targets delivery of oxygen to ischemic tissues. This study will evaluate the safety and efficacy of MP4OX treatment in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock. The study hypothesis is that MP4OX will reverse the lactic acidosis by enhancing perfusion and oxygenation of ischemic tissues and thereby prevent and reduce the duration of organ failure and improve outcome in these patients.

NCT ID: NCT01261611 Completed - Cervical Dystonia Clinical Trials

Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia

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

The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an approved drug called Dysport.

NCT ID: NCT01258439 Completed - HIV Clinical Trials

Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART.

ROaR+
Start date: November 2010
Phase: Phase 4
Study type: Interventional

This is a research study into the effects of three drugs used to treat HIV infection. Some drugs used to treat HIV have been associated with changes in blood fats such as cholesterol that could be harmful over the long-term, because these blood fat changes have been associated with a small, increased risk of heart disease and stroke in some studies of adults with HIV. Now that HIV can be controlled for long periods in most patients, and because heart disease is one of the biggest causes of illness and death in the general population, it is important to develop new HIV treatments that control HIV effectively but do not cause abnormal blood fats. Hypothesis: That Raltegravir will result in less post-prandial lipid disturbances than ritonavir-boosted darunavir.

NCT ID: NCT01258205 Completed - Crohn's Disease Clinical Trials

Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects

Start date: February 28, 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD).

NCT ID: NCT01258088 Completed - Clinical trials for Plaque-type Psoriasis

Safety Study of Ointment for the Treatment of Plaque-type Psoriasis

AN2728-PSR-104
Start date: November 30, 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine how much drug is absorbed throughout the body after being applied to the skin.

NCT ID: NCT01257204 Completed - Hepatitis C Virus Clinical Trials

Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection

Start date: December 2010
Phase: Phase 2
Study type: Interventional

To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.

NCT ID: NCT01254279 Completed - Clinical trials for Prostate Cancer Metastatic

Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

Start date: December 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or after docetaxel and to document the overall safety of cabazitaxel in these patients. Please note that in each country, patient recruitment will end when cabazitaxel becomes commercially available.

NCT ID: NCT01254188 Completed - Clinical trials for Chronic Myeloid Leukemia

Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients

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

This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase