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NCT ID: NCT00533637 Completed - Allergic Rhinitis Clinical Trials

Taste and Local Tolerance Study of NLA Nasal Spray in Patients With Allergic Rhinitis

Start date: September 2007
Phase: Phase 2
Study type: Interventional

Evaluation of NLA Nasal Spray with regard to taste perversion and local tolerance

NCT ID: NCT00532155 Completed - Carcinoma Clinical Trials

A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

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

The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). The secondary objectives were to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this participant population and to determine immunogenicity of IV aflibercept in all participants.

NCT ID: NCT00531804 Completed - Alzheimer's Disease Clinical Trials

A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.

Start date: December 2006
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

NCT ID: NCT00531622 Completed - Clinical trials for Major Depressive Disorder

An Eight-Week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder

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

The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).

NCT ID: NCT00530842 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Effect of Tiotropium Plus Salmeterol vs. Fluticasone/Salmeterol on Static Lung Volumes and Exercise Endurance in COPD

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

The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD. The secondary objective includes assessment of safety.

NCT ID: NCT00530348 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One

CARE-MS I
Start date: August 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disease-modifying therapies. Participants had monthly laboratory tests and comprehensive testing every 3 months.

NCT ID: NCT00530075 Completed - Clinical trials for Wegener's Granulomatosis

Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis

Start date: December 2003
Phase: Phase 2
Study type: Interventional

Wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and necrotizing inflammation predominantly affecting the respiratory tract and the kidneys. Conventional therapy of Wegener's granulomatosis with cyclophosphamide and corticosteroids is limited by incomplete remissions and a high relapse rate. Patients accumulate irreversible damage due to the disease and the consequences of prolonged drug exposure. The efficacy and safety of an alternative immunosuppressive drug, gusperimus, was evaluated in patients with refractory disease. A prospective, international, nulti-centre, single limb, open label study. Entry required active Wegener's granulomatosis with a Birmingham Vasculitis Activity Score (BVAS) >=4 and previous therapy with cyclophosphamide or methotrexate. Immunosuppressive drugs were withdrawn at entry and prednisolone doses adjusted according to clinical status. Gusperimus, 0.5mg/kg/day, was self-administered by subcutaneous injection in six treatment cycles of 21 days with a seven day washout between cycles. Cycles were stopped early for white blood count < 4,000/mm3. The primary endpoint was complete remission (BVAS=0 for at least 2 months) or partial remission (BVAS<50% of entry score). After the sixth cycle azathioprine was commenced and follow-up continued for a further six months.

NCT ID: NCT00528567 Completed - Breast Cancer Clinical Trials

BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer

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

The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab. The secondary objectives of this trial are to: - compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab - evaluate the safety and tolerability of bevacizumab An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.

NCT ID: NCT00528112 Completed - Contraception Clinical Trials

Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

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

This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years

NCT ID: NCT00527332 Completed - Clinical trials for Hysterectomy (MeSH nr: E04.950.300.399)

Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy

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

The purpose of this study is to determine whether spinal anesthesia combined with intrathecal morphine in abdominal hysterectomy on benign gynecological indications gives better outcome concerning duration of hospital stay and postoperative patient comfort than general anesthesia.