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NCT ID: NCT00921726 Completed - Influenza Clinical Trials

Pharmacokinetic Study of Oseltamivir and Intravenous Zanamivir in Healthy Adults

Start date: July 2009
Phase: Phase 1
Study type: Interventional

Due in part to widespread availability of oseltamivir and clinical experience using oseltamivir to treat H5N1 influenza virus infections, many strains of influenza have become resistant to it. Other reliable methods of treating H5N1 must be identified in case of a pandemic. One such option is intravenous zanamivir used in combination with oseltamivir. The primary purpose of this study is to evaluate the interaction between oral oseltamivir and intravenous zanamivir administered as either a continuous or intermittent infusion in healthy adults.

NCT ID: NCT00920192 Completed - Clinical trials for Carcinoma, Hepatocellular

Safety Study of Foretinib (GSK1363089) in Adults With Liver Cancer

Start date: August 12, 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of foretinib (also known as GSK1363089) when used in the treatment of patients with advanced hepatocellular carcinoma (liver cancer).

NCT ID: NCT00919841 Completed - Healthy Clinical Trials

Sequential Volume Measurement of Postpartum Uterus Using 3-dimensional Sonographies

3DUT
Start date: July 2009
Phase: N/A
Study type: Observational

Women who naturally deliver a singleton will be invited to participate the study. Weekly transabdominal and/or transvaginal ultrasound examinations will be offered until the uterus is completely involuted. The pattern of involution will be analyzed.

NCT ID: NCT00919295 Completed - Clinical trials for Fibromyalgia Syndrome

Study of Indoleamine 2,3-dioxygenase Activity, Serum Levels of Cytokines, BDNF, BH4 and Mirtazapine Efficacy in Fibromyalgia Syndrome

Start date: December 2008
Phase: Phase 2
Study type: Interventional

This study aims to investigate the anti-nociceptive biogenic amine (serotonin [5-hydroxytryptamine; 5-HT], norepinephrine [NE], dopamine [DA], and their metabolites) status, and serum levels of cytokines, BDNF and BH4 in Thai fibromyalgia syndrome (FMS) patients compared with a representative Thai population. The efficacy and the tolerability of mirtazapine as monotherapy for FMS will also be assessed. In addition, proof of concept of the indoleamine 2,3-dioxygenase (IDO) activity in FMS will be conducted. The study will be divided into three parts. In part I, FMS patients of Thai ethnicity will be examined to determine the blood and/or urinary level of anti-nociceptive biogenic amines, cytokines, BDNF and BH4 by comparison with the demographically matched, but unrelated, healthy normal controls (HNC). In part II, the FMS subjects from part I study will be randomized to blinded therapy with mirtazapine or identical appearing placebo. There will be three treatment groups (N=1:1:1) to accommodate two dosages of mirtazapine (15 mg, 30mg) and placebo given before bedtime. Pill counts at baseline and at follow-up visits will document compliance. Standard outcome instruments (translated and validated in Thai language) will be used at baseline and at each of the follow-up visits. The co-primary outcome variable will be the changes in the pain visual analog scale (PVAS) score and pain responders (>= 30% PVAS reduction). Secondary clinical outcome variables of interest will include depression, insomnia, anxiety, physical function, morning stiffness, patient global assessment of disease status, patient global impression of change, fibromyalgia impact questionnaire (FIQ, quality of life and adverse experience. The changes of biogenic amine and IGF-1 concentrations in blood and/or urine with the treatment will be examined as the secondary biochemical measures. In part III, the IDO activity of depressed FMS, non-depressed FMS and HNC will be compared. Moreover, the effect of mirtazapine treatment on the IDO activity in depressed and non-depressed FMS patients will be assessed. Study hypothesis 1. Anti-nociceptive biogenic amine levels in Thai FMS patients are lower than in Thai healthy normal control. 2. Higher IDO activity could be observed in FMS patients. 3. Higher cytokines could be observed in FMS patients. 4. Higher BDNF could be observed in FMS patients. 5. Lower BH4 could be observed in FMS patients. 6. Mirtazapine is effective in FMS treatment.

NCT ID: NCT00917384 Completed - Gastric Cancer Clinical Trials

Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma

Start date: August 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to gather information about the use of an investigational drug called Ramucirumab in adenocarcinomas of the stomach or gastroesophageal junction.

NCT ID: NCT00917254 Completed - Clinical trials for Venous Thromboembolism

Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

Start date: May 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery.

NCT ID: NCT00913120 Completed - Clinical trials for Venous Thromboembolism

Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery

Start date: May 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total hip replacement surgery.

NCT ID: NCT00911196 Completed - Clinical trials for Hepatocellular Carcinoma

Analysis of Expression of Specific Markers and Their Prognostic Significance in Hepatocellular Carcinoma

Start date: November 2008
Phase: N/A
Study type: Observational

Hepatocellular carcinoma is an aggressive disease with limited therapeutic options. Therefore, new approaches to treat this type of cancer are needed with immunotherapy potentially being one of these. As a first step in the development of novel therapies, expression analysis of specific markers, including tumor antigens will be carried out, and the correlation of expression with disease variables and clinical outcome will be assessed. This will be done retrospectively using archived hepatocellular carcinoma tissue samples.

NCT ID: NCT00910871 Completed - Tuberculosis Clinical Trials

To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB

NCT ID: NCT00909597 Completed - Clinical trials for Diabetes Mellitus Type 2

A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

Start date: May 2009
Phase: Phase 3
Study type: Interventional

This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.