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NCT ID: NCT00368121 Terminated - Multiple Myeloma Clinical Trials

EMMA-1 (Erbitux for Multiple Myeloma)

EMMA-1
Start date: August 2006
Phase: Phase 2
Study type: Interventional

EMMA-1 is an open-label, non-randomized, two-stage phase II study. Patients with refractory multiple myeloma stage II or III or relapsed disease after at least one line of treatment will receive Cetuximab+/-Dexamethasone. The planed treatment duration per patient is 16 weeks. Patients achieving a response or stable disease after 16 weeks of treatment may continue study medication for 6 more months (patients receiving Cetuximab alone) or for 3 more months (patients receiving Cetuximab plus Dexamethasone). Responding patients who relapse during follow-up period of two years may receive a second treatment with Cetuximab following initial study guidelines

NCT ID: NCT00366912 Terminated - Respiratory Failure Clinical Trials

Unloading Respiratory Muscles During NIV: Comparison of a Spontaneous and Auto-adjusting Controlled Mode

Start date: August 2006
Phase: N/A
Study type: Interventional

Measurement of Work of breathing (WOB), as well as pressure time product (PTP) of transdiaphragmatic pressures to evaluate the degree of muscle activity and muscle unloading during non-invasive ventilation. The study makes comparison of a new developed auto adjusting controlled mode and a regular spontaneous mode.

NCT ID: NCT00366795 Terminated - Liver Cirrhosis Clinical Trials

Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

SPARe-2
Start date: August 2006
Phase: Phase 3
Study type: Interventional

Primary: To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites. Secondary: To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

NCT ID: NCT00366080 Terminated - Narcolepsy Clinical Trials

Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy

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

The purpose of this study is to assess the effectiveness and safety of the drug GSK189254 in treating patients with narcolepsy.

NCT ID: NCT00361868 Terminated - Dyslipidemia Clinical Trials

Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

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

Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is superior to that of rosiglitazone.

NCT ID: NCT00360412 Terminated - Parkinson's Disease Clinical Trials

A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

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

Patients who have completed one of the core trials (E2007-E044-301 or E2007-A001-302) and who meet inclusion/exclusion criteria will be enrolled and will enter the Titration Phase, lasting 4 weeks (weeks 0-3) followed by the Maintenance Phase, lasting 52 weeks (weeks 4-56). All patients will receive active study drug. During the Titration Phase, patients will receive E2007 2 mg once daily (o.d.) for 2 weeks followed by 4 mg o.d. for 2 weeks. During the Maintenance Phase, patients will receive 4 mg o.d. Patients not tolerating the study drug at 4 mg, will be allowed to down titrate to 2 mg. Patients not tolerating 2 mg will be withdrawn from the study. Patients will have visits at 2, 4, 8, 20, 32, 44, and 56 weeks after study entry. In addition, a follow-up visit will occur 4 weeks after study treatment has ended (week 60). A home diary will be completed in which patients rate themselves as either: 1. OFF 2. ON without dyskinesia 3. ON with non-troublesome dyskinesias 4. ON with troublesome dyskinesias 5. Asleep These entries will be completed every half hour during the waking day and will be completed for 3 consecutive days following the visits at weeks 4, 8, 20, 32 and 44, and three days prior to the visits at weeks 56 and 60. At entry into the study (week 0) and at weeks 8, 20, 32, 44 and 56, the Unified Parkinson's Disease Rating Scale (UPDRS), Clinician's Global Impression of Change (CGIC) and Clinical Global Impression of Tolerance (CGIT) will be performed.

NCT ID: NCT00359437 Terminated - Liver Cirrhosis Clinical Trials

Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

SPARe-1
Start date: July 2006
Phase: Phase 3
Study type: Interventional

Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

NCT ID: NCT00359424 Terminated - Stroke Clinical Trials

Interventional Management of Stroke (IMS) III Trial

IMSIII
Start date: August 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset—combined intravenous (IV) and endovascular therapy and standard intravenous (IV) rt-PA alone.

NCT ID: NCT00355901 Terminated - Ulcerative Colitis Clinical Trials

An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

Start date: September 2006
Phase: Phase 2
Study type: Observational

To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.

NCT ID: NCT00349752 Terminated - Crohn's Disease Clinical Trials

Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease

COSPAR1
Start date: November 2006
Phase: Phase 3
Study type: Interventional

The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease. Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization.