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NCT ID: NCT00353496 Completed - Endocrine Tumors Clinical Trials

Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours

CLARINET
Start date: June 2006
Phase: Phase 3
Study type: Interventional

The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.

NCT ID: NCT00351468 Completed - Clinical trials for Purpura, Thrombocytopaenic, Idiopathic

EXTEND (Eltrombopag Extended Dosing Study)

EXTEND
Start date: June 2006
Phase: Phase 3
Study type: Interventional

An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/microL will be investigated.

NCT ID: NCT00351143 Completed - Asthma Clinical Trials

A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control

Start date: July 26, 2005
Phase: Phase 4
Study type: Interventional

This study will investigate whether study subjects with previously uncontrolled asthma treated with SERETIDE Diskus 50/250 CCI18781+GR33343 mcg twice a day can attain a level of Total Control of their condition and whether adherence to treatment can be enhanced by teaching the subjects. Two groups of equal size with identical medical treatment will be compared with each other, the test group receiving three training modules during study visits and the control group regular study visits only.

NCT ID: NCT00350961 Completed - Cholangiocarcinoma Clinical Trials

Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma

Start date: June 2004
Phase: Phase 1/Phase 2
Study type: Interventional

In Denmark approximately 200 new cases of cholangiocarcinoma are diagnosed every year. No standard treatment exists for patients with advanced cholangiocarcinoma, and improved systemic treatments are needed. Duplets of gemcitabine, oxaliplatin and capecitabine have been evaluated in various cancers and several different regimens are well tolerated and active, especially in upper gastrointestinal cancers, exocrine pancreatic cancer and non-small cell lung cancer. The triplet combination of these agents has not been studied, but a triplet combination of gemcitabine, oxaliplatin and 5-FU infusion has been evaluated in a phase I study. Bi-weekly combination of gemcitabine and oxaliplatin has proven active and tolerable and warrants further study. In addition, fixed dose rate infusion of gemcitabine has shown interesting as the ability of mononuclear cells to accumulate gemcitabine triphosphate during therapy seems to be saturable. We propose a phase I-II study of a bi-weekly schedule of gemcitabine, oxaliplatin and capecitabine. This regimen could be feasible in an out-patients setting. The phase I part is a standard dose escalation study for patients with solid tumors. In the phase II part the recommended dose is studied in patients with advanced cholangiocarcinoma.

NCT ID: NCT00350753 Completed - Cholangiocarcinoma Clinical Trials

Avastin and Tarceva for Upper Gastrointestinal Cancers

Start date: June 2006
Phase: Phase 2
Study type: Interventional

Erlotinib and bevacizumab have shown activity individually, as single drugs, or in combination with chemotherapy in upper gastro-intestinal cancers, including esophageal and gastro-esophageal adenocarcinomas, gastric cancer and pancreatic cancer. Biomarkers indicating an important role of EGF and VEGF have been found in these tumors, and in cholangiocarcinomas as well. There is promise that combined treatment with erlotinib and bevacizumab is active and tolerable in a broad range of upper gastro-intestinal cancers, justifying an experimental phase II-study of patients with these diagnoses, refractory or intolerant to standard systemic therapy.

NCT ID: NCT00350207 Completed - Asthma Clinical Trials

Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

Start date: July 2006
Phase: Phase 2
Study type: Interventional

This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks. The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.

NCT ID: NCT00349531 Completed - Clinical trials for Restless Legs Syndrome

A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS

Start date: July 2006
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to investigate the effects on RLS symptoms and sleep disturbance of pramipexole (Mirapexin) 0.125 mg/day to 0.75 mg/day per os for 12 weeks, compared to placebo, in the treatment of patients with idiopathic Restless Legs Syndrome

NCT ID: NCT00349375 Completed - Hyperlipidemia Clinical Trials

Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

Start date: November 2005
Phase: Phase 3
Study type: Interventional

Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

NCT ID: NCT00346996 Completed - Type 1 Diabetes Clinical Trials

Insulin Analogues and Severe Hypoglycaemia

Start date: May 2007
Phase: Phase 4
Study type: Interventional

Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia

NCT ID: NCT00346034 Completed - Fibromyalgia Clinical Trials

This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

Start date: December 2006
Phase: Phase 3
Study type: Interventional

The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.