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NCT ID: NCT02116569 Completed - Multiple Myeloma Clinical Trials

A Study of Daratumumab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Start date: April 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the tolerability and safety of Daratumumab in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma (cancer of plasma cells in bone marrow, characterized by the presence of abnormal proteins in the blood).

NCT ID: NCT02115750 Completed - Clinical trials for Rheumatoid Arthritis

Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)

CHS-0214-02
Start date: May 2014
Phase: Phase 3
Study type: Interventional

This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies. Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety. Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.

NCT ID: NCT02114658 Completed - Thyroid Carcinoma Clinical Trials

Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients

Start date: April 15, 2014
Phase: Phase 2
Study type: Interventional

The objectives of this study are to evaluate safety, efficacy and pharmacokinetics of sorafenib for the treatment of Japanese patients with anaplastic thyroid carcinoma (ATC) or locally advanced or metastatic medullary thyroid carcinoma (MTC).

NCT ID: NCT02113137 Completed - Halitosis Clinical Trials

Oral Hygiene Procedures on Reduction of Oral Malodor

Start date: September 2013
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate the effect of various oral hygiene procedures on reduction of oral malodor.

NCT ID: NCT02113020 Completed - Clinical trials for Clinical Pharmacology

A Phase I Clinical Pharmacology Study of TAK-233 in Healthy Subjects

Start date: February 2014
Phase: Phase 1
Study type: Interventional

The objective of this clinical trial is to examine the clinical pharmacology properties of TAK-233 in healthy female subjects

NCT ID: NCT02111252 Completed - Influenza Clinical Trials

A Phase 1/2 Study of a Intramuscular Injection of TAK-850 in Healthy Adult Subjects

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

This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in healthy Japanese adult participants

NCT ID: NCT02108964 Completed - Clinical trials for Advanced Non-small Cell Lung Cancer

A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies

Start date: June 6, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II, multi-center, open-label study, composed with a Phase I part (dose-escalation phase) followed by a Phase II part (expansion phase). The dose escalation phase was designed to determine as primary objective the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of EGF816 monotherapy in adult subjects with locally advanced (stage IIIB) or metastatic (stage IV) NSCLC harboring specific EGFR mutations. Patients may have or not have received prior lines of antineoplastic therapy. An adaptive Bayesian Logistic Regression Model (BLRM) employing the escalation with overdose control (EWOC) principle will be used during the dose escalation part for dose level selection and MTD recommendation. The primary objective of the Phase II part is to estimate antitumor activity of EGF816 as measured by overall response rate (ORR) determined by Blinded Independent Review Committee (BIRC) assessment in accordance to RECIST 1.1.

NCT ID: NCT02108288 Completed - Glaucoma Clinical Trials

Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers

Start date: April 2014
Phase: Phase 1
Study type: Interventional

OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost ophthalmic solution are administered once daily for 7 days and the effect on the blood concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating the combination drug will be determined.

NCT ID: NCT02107898 Completed - Clinical trials for Hypercholesterolemia

Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)

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

Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with placebo after 24 weeks of treatment in heterozygous familial hypercholesterolemia (HeFH) or high cardiovascular risk participants with hypercholesterolemia. Secondary Objectives: - To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment. - To evaluate the effect of alirocumab on other lipid parameters. - To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C after 52 weeks of treatment. - To evaluate the safety and tolerability of alirocumab. - To evaluate the development of anti-alirocumab antibodies. - To evaluate the pharmacokinetics of alirocumab.

NCT ID: NCT02106455 Completed - Clinical trials for Osseous Paget's Disease

Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance −

Start date: August 1, 2008
Phase:
Study type: Observational

The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets administered once daily (one tablet per dose) in patients with osseous Paget's disease for 48 weeks from baseline in daily medical practice.