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NCT ID: NCT00679380 Completed - Ulcerative Colitis Clinical Trials

(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

Start date: June 2008
Phase: Phase 3
Study type: Interventional

This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period. After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.

NCT ID: NCT00679224 Completed - Clinical trials for Hypertension, Pulmonary

An Observational Study For Ambrisentan

VOLT
Start date: June 2008
Phase: N/A
Study type: Observational

The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice

NCT ID: NCT00678535 Completed - Gastric Cancer Clinical Trials

Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer

EXPAND
Start date: June 2008
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS). Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.

NCT ID: NCT00678392 Completed - Kidney Neoplasms Clinical Trials

Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

Start date: September 3, 2008
Phase: Phase 3
Study type: Interventional

The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.

NCT ID: NCT00677066 Completed - Bronchiolitis Clinical Trials

Safety Study of Home Oxygen Therapy for Children With Acute Bronchiolitis

Start date: August 2007
Phase: Phase 3
Study type: Interventional

Home oxygen therapy is considered an appropriate and relatively safe option for children with chronic respiratory problems such as chronic lung disease of prematurity, but the use of home oxygen therapy for children with acute respiratory problems is limited. With the recent establishment of a "Hospital in The Home" (HiTH) program at our institution, we sought to determine the safety, parental satisfaction and economic advantage of home oxygen therapy for children with acute bronchiolitis compared with traditional inpatient hospitalization.

NCT ID: NCT00675116 Completed - Healthy Subjects Clinical Trials

GW823296 Repeat Dose Study In Healthy Male And Female Subjects

Start date: April 2008
Phase: Phase 1
Study type: Interventional

This is a study to evaluate the safety, tolerability and pharmacokinetics of GW823296 following 28 days, once-daily repeat oral doses.

NCT ID: NCT00675090 Completed - Alzheimer's Disease Clinical Trials

Bridging Study With GSK239512 In Patients With Mild To Moderate Alzheimer's Disease

Start date: February 21, 2008
Phase: Phase 1
Study type: Interventional

This is a safety and tolerability study to investigate the effect of GSK239512 on mild to moderate Alzheimers disease patients. The dose of GSK239512 will be titrated to reach the most well tolerated dose in the patients.

NCT ID: NCT00674973 Completed - Pancreatic Cancer Clinical Trials

A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer

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

This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

NCT ID: NCT00674635 Completed - Clinical trials for Arthritis, Rheumatoid

Phase II Study Evaluating the Safety and Efficacy of GSK315234A in Patients With Rheumatoid Arthritis

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

This is a randomized, double-blinded, placebo-controlled adaptive, dose finding study to investigate the safety, tolerability, PK, PD and efficacy of single and repeat intravenous infusions of GSK315243A in patients with active rheumatoid arthritis. The study is divided into 2 parts: Part A is an adaptive, dose finding phase which will provide safety, tolerability, PK and PD on single intravenous infusions. Part B is a repeat dose phase which will provide safety, tolerability, PK, PD and efficacy following repeat intravenous infusions of a selected dose level.

NCT ID: NCT00674193 Completed - Clinical trials for Unspecified Childhood Solid Tumor, Protocol Specific

Evaluating Dactinomycin and Vincristine in Young Patients With Cancer

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

This laboratory study is evaluating how well dactinomycin and vincristine work in treating young patients with cancer. Studying samples of blood and urine in the laboratory from patients with cancer may help doctors learn how dactinomycin and vincristine affect the body and how patients will respond to treatment.