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NCT ID: NCT02104245 Completed - Clinical trials for Non Cystic Fibrosis Bronchiectasis

Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)

Start date: May 28, 2014
Phase: Phase 3
Study type: Interventional

This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.

NCT ID: NCT02104219 Completed - Clinical trials for Hypophosphatasia (HPP)

Retrospective, Non-interventional Natural History of Patients With Juvenile-onset Hypophosphatasia (HPP)

Start date: March 2014
Phase:
Study type: Observational

The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP.

NCT ID: NCT02103335 Completed - Multiple Myeloma Clinical Trials

Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone in Relapsed and Refractory Multiple Myeloma

Start date: June 5, 2014
Phase: Phase 1
Study type: Interventional

This is a Phase 1 clinical trial to evaluate a new combination of drugs for the treatment of relapsed or refractory (drug-resistant) multiple myeloma. The drugs being studied are: - Pomalidomide (POMALYST®) is a drug that affects the immune system (an immunomodulatory drug) that has been approved by the United States (US) Food and Drug Administration (FDA) for the treatment of multiple myeloma. - Marizomib is an investigational drug being developed by Triphase that is being studied for the treatment of multiple myeloma. Investigational drugs are drugs that have not yet been approved by health authorities, such as the FDA, for general use but have been approved for use in specific clinical studies. Marizomib inhibits a cellular machine called the proteasome, which destroys unnecessary or damaged proteins. Other proteasome inhibitors have been shown to be effective in the treatment of multiple myeloma. - Dexamethasone is a corticosteroid drug that affects the immune system (an immunomodulatory drug) that has been approved by the FDA for the treatment of multiple myeloma. This is the first study to evaluate the three-drug combination of pomalidomide (POM), marizomib (MRZ), and dexamethasone (LD-DEX) in humans. Pomalidomide, alone or in combination with dexamethasone, is approved by the FDA for the treatment of relapsed or refractory multiple myeloma. The primary objective of this study is to determine the best drug dosing levels for this three-drug combination, including the highest safe doses and/or the recommended doses for future clinical studies of this drug combination. The secondary purposes of this study are to determine the safety of this drug combination and its effectiveness in treating relapsed or refractory multiple myeloma. The study will include examination of levels of all three drugs in the blood during various time points during treatment.

NCT ID: NCT02102204 Completed - Clinical trials for Hyperparathyroidism, Secondary

Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

Start date: March 25, 2014
Phase: Phase 3
Study type: Interventional

This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

NCT ID: NCT02100839 Completed - Clinical trials for Hypercholesterolemia

Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia

Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the first part of this study is to determine the safety and tolerability of a single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol who are otherwise healthy subjects. The pharmacokinetics and pharmacodynamics of AEM-28 will also be evaluated. The second part of this study will be a multiple ascending dose evaluation of AEM-28 in patients with refractory hypercholesterolemia. AEM-28 has demonstrated significant lipid lowering activity and positive effects on the artery wall. AEM-28 is being developed for the treatment of homozygous familial hypercholesterolemia.

NCT ID: NCT02100696 Completed - Ulcerative Colitis Clinical Trials

A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors

HICKORY
Start date: May 21, 2014
Phase: Phase 3
Study type: Interventional

This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.

NCT ID: NCT02100475 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification

DUALâ„¢
Start date: April 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to compare sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensification. This is an extension to trial NN9068-3952, NCT01952145 (DUALâ„¢ V).

NCT ID: NCT02097875 Completed - Skin Neoplasms Clinical Trials

Safety Study of a Fluorescent Marker to Visualize Cancer Cells

Start date: December 2013
Phase: Phase 1
Study type: Interventional

Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have spread from the original tumor site, resulting in incomplete removal of the tumor and reduced patient survival. In addition, in some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumor to prevent adverse effects of surgery on function. We hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time, as they operate.

NCT ID: NCT02097485 Completed - Clinical trials for Head Lice Infestation

Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation

Start date: May 2014
Phase: Phase 2
Study type: Interventional

The purpose of the study was to evaluate ovicidal efficacy of a single application of abametapir lotion 0.74% w/w intended for the treatment of head lice.

NCT ID: NCT02094586 Completed - Cholera Clinical Trials

A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults

Start date: May 2014
Phase: Phase 3
Study type: Interventional

The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.