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NCT ID: NCT00806923 Completed - Clinical trials for Non-Squamous Non-Small Cell Lung Cancer

A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

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

This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

NCT ID: NCT00806104 Completed - Clinical trials for Irritable Bowel Syndrome

Fructo-oligosaccharides and Irritable Bowel Syndrome

Start date: March 2009
Phase: N/A
Study type: Interventional

Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve IBS score and to explore which modifications of the microbiota are responsible of this improvement.

NCT ID: NCT00806026 Completed - Clinical trials for Idiopathic Restless Legs Syndrome

Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

RLS
Start date: December 2008
Phase: Phase 3
Study type: Interventional

This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.

NCT ID: NCT00805194 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer

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

The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.

NCT ID: NCT00805168 Completed - Clinical trials for Pneumonia, Bacterial

Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

INHALE 2
Start date: May 28, 2013
Phase: Phase 3
Study type: Interventional

To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on ventilation, and the days in the intensive care unit (ICU).

NCT ID: NCT00804986 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study for Patients With Type 2 Diabetes Mellitus

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

A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet and exercise alone, or in combination with metformin, will be enrolled. The primary objective of this study is to test the hypothesis that LY2428757 given to patients with T2DM inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week safety follow-up.

NCT ID: NCT00804414 Completed - Diabetes Clinical Trials

Efficacy and Safety Study of Soluble Beta-1,3/1,6-glucan (SBG) Versus Placebo in Chronic Diabetic Foot Ulcers

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

Evaluation of efficacy and safety of SBG vs placebo in the treatment of chronic diabetic foot ulcers.

NCT ID: NCT00804141 Completed - Constipation Clinical Trials

Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation

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

This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study.

NCT ID: NCT00803244 Completed - Primary Disease Clinical Trials

Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis (With or Without Asthma)

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

The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.

NCT ID: NCT00803205 Completed - Cystic Fibrosis Clinical Trials

Study of Ataluren (PTC124™) in Cystic Fibrosis

Start date: September 8, 2009
Phase: Phase 3
Study type: Interventional

Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 trial that will evaluate the clinical benefit of ataluren in adult and pediatric participants with CF due to a nonsense mutation. The main goals of the study are to understand whether ataluren can improve pulmonary function and whether the drug can safely be given for a long period of time. The study will also assess the effects of ataluren on CF pulmonary exacerbation frequency, cough frequency, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology.