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NCT ID: NCT02500316 Completed - Clinical trials for Growth Hormone Deficiency (GHD)

Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

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

Protocol CP-4-004-EXT is designed as a long-term, open-label extension using single patient use, multi-dose, disposable pre-filled pen.

NCT ID: NCT02499770 Completed - Clinical trials for Small Cell Lung Cancer

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)

Start date: June 26, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.

NCT ID: NCT02499120 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer

Start date: September 10, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naive patients with recurrent/metastatic squamous cell carcinoma of the head and neck.

NCT ID: NCT02497781 Completed - Clinical trials for Complicated Urinary Tract Infections

Evaluation of Safety, Pharmacokinetics and Efficacy of Ceftazidime and Avibactam (CAZ-AVI ) Compared With Cefepime in Children From 3 Months to Less Than 18 Years of Age With Complicated Urinary Tract Infections (cUTIs)

Start date: September 24, 2015
Phase: Phase 2
Study type: Interventional

This study will assess the safety, tolerability and efficacy of ceftazidime and avibactam (CAZ-AVI )versus cefepime in children from 3 months to less than 18 years old with complicated urinary tract infections.

NCT ID: NCT02497716 Completed - Thrombosis Clinical Trials

Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children

Start date: November 4, 2015
Phase: Phase 1
Study type: Interventional

To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability

NCT ID: NCT02497469 Completed - Colitis, Ulcerative Clinical Trials

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

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

The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

NCT ID: NCT02496884 Completed - Fibromyalgia Clinical Trials

Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease

Start date: June 26, 2015
Phase: Phase 3
Study type: Interventional

DS-5565 (mirogabalin) is being studied as treatment for fibromyalgia (FM) pain. Because it is excreted through the kidneys, people who have reduced kidney function will not process the drug as well as with those with normal kidney function, so the dose must be reduced. This study will test two reduced dose levels for both moderately reduced and severely reduced kidney function. The study will test the hypothesis that the drug will be safe and well-tolerated in people who have both fibromyalgia and chronic kidney disease.

NCT ID: NCT02495974 Completed - Clinical trials for Metastatic Castration Resistant Prostate Cancer

European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

PREMISE
Start date: September 8, 2015
Phase:
Study type: Observational

The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as measured by time to treatment failure defined as the time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.

NCT ID: NCT02495844 Completed - Clinical trials for Highly Drug-resistant Focal Epilepsy

A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

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

This study is to assess the efficacy, safety, and tolerability of the investigational drug UCB0942in adult subjects with drug-resistant focal epilepsy across multiple centers in Europe.

NCT ID: NCT02493868 Completed - Clinical trials for Depressive Disorder, Treatment-Resistant

A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression

SUSTAIN-1
Start date: October 1, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in participants with treatment-resistant depression (TRD) who are in stable remission after an induction and optimization course of intranasal esketamine plus an oral antidepressant.