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NCT ID: NCT00468728 Completed - Diarrhea Clinical Trials

PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

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

This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

NCT ID: NCT00466167 Completed - Parkinson Disease Clinical Trials

Pivotal Study in Advanced Parkinsons Disease Patients

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

The general aim of this trial is to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for Unified Parkinsons Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER, in daily doses from 0.375 milligram to 4.5 milligram once a day, in comparison to placebo, in Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with advanced Parkinsons Disease and motor fluctuations. In addition, a numerical comparison of the efficacy of pramipexole extended release versus pramipexole immediate release will be done. The efficacy of pramipexole immediate release will also be compared to placebo, for assay sensitivity.

NCT ID: NCT00465816 Completed - Clinical trials for Infections, Meningococcal

Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612

Start date: April 11, 2007
Phase: Phase 3
Study type: Interventional

This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.

NCT ID: NCT00464165 Completed - Smoking Cessation Clinical Trials

Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation

STRATUS-EU
Start date: November 2002
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers. The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of abstinent subjects during a 40-week follow-up post treatment.

NCT ID: NCT00463866 Completed - Asthma Clinical Trials

Local Phase 4 Pan-European SMART Study

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

The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

NCT ID: NCT00463567 Completed - COPD Clinical Trials

26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Start date: April 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 & 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD

NCT ID: NCT00462007 Completed - Parkinson's Disease Clinical Trials

Study to Evaluate Initiation of Stalevo in Early Wearing-off

SENSE
Start date: September 2006
Phase: Phase 4
Study type: Interventional

An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The study will consist of 2 consecutive periods: screening period and study treatment period. Duration of the study will be up to 8 weeks for each subject. The study treatment dosage will be determined by the subject's current, separately administered standard levodopa/DDCI treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be switched to an equivalent dose of Stalevo® without changing the number of doses per day. The levodopa daily dose during Stalevo® treatment may be adjusted according to the study subject's clinical response.

NCT ID: NCT00460512 Completed - Schizophrenia Clinical Trials

An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia

PERFlexS
Start date: April 25, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to explore tolerability, safety and effectiveness of flexibly dosed paliperidone extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with an oral antipsychotic medication.

NCT ID: NCT00460408 Completed - Clinical trials for Macular Degeneration

Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration

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

The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.

NCT ID: NCT00459706 Completed - Clinical trials for Rheumatoid Arthritis

Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

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

The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in patients with rheumatoid arthritis (RA).