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NCT ID: NCT01125566 Completed - Breast Neoplasms Clinical Trials

LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

Start date: June 22, 2010
Phase: Phase 3
Study type: Interventional

To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

NCT ID: NCT01125410 Completed - Bacterial Vaginosis Clinical Trials

Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis

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

The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis.

NCT ID: NCT01124786 Completed - Clinical trials for Metastatic Pancreatic Adenocarcinoma

A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)

Start date: May 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.

NCT ID: NCT01124149 Completed - Ulcerative Colitis Clinical Trials

Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis

Start date: June 29, 2010
Phase: Phase 4
Study type: Interventional

This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore, subjects who achieve either complete or partial remission will enter into a 12-month maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given QD. Remission status for the 2 groups will be evaluated and compared at the end of this 12-month maintenance period. The data obtained from this study will provide scientifically meaningful information to demonstrate that achieving complete remission (clinical and endoscopic remission) is important for a better long-term prognosis, or that the current paradigm of symptomatic treatment is appropriate.

NCT ID: NCT01123941 Completed - Typhoid Fever Clinical Trials

Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)

Start date: May 2010
Phase: Phase 1
Study type: Interventional

This trial is aimed to evaluate the safety and immunogenicity profiles of a new Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently licensed Vi polysaccharide vaccine.

NCT ID: NCT01123512 Completed - Spinal Fractures Clinical Trials

The Kiva® System as a Vertebral Augmentation Treatment

KAST
Start date: July 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or lumbar spine.

NCT ID: NCT01122797 Completed - Clinical trials for Alcoholic Liver Disease

Influence of Adiponutrin in Chronic Liver Disease

Start date: January 2003
Phase: N/A
Study type: Observational

Increasing evidence attests the influence of multiple metabolic genetic risk factors in the progression of alcoholic liver disease. Deleterious pathways involved in metabolism such as lipid peroxidation and cytokines have been implicated in promoting inflammation leading to fibrosis increase and liver injury progression. The aim of this study was to assess the role of rs738409 single nucleotide polymorphism in the PNPLA3 gene in alcoholic liver disease patients.

NCT ID: NCT01122472 Completed - Lymphoma Clinical Trials

Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP

REMARC
Start date: April 2009
Phase: Phase 3
Study type: Interventional

This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant.

NCT ID: NCT01122368 Completed - Mycoses Clinical Trials

A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects

INTENSE
Start date: July 13, 2010
Phase: Phase 2
Study type: Interventional

Subjects with intra-abdominal infection requiring surgery and Intensive Care Unit stay will be treated early with micafungin or placebo to determine the incidence and time to confirmation of fungal infection.

NCT ID: NCT01121406 Completed - Ovarian Neoplasms Clinical Trials

BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer

Start date: April 2010
Phase: Phase 2
Study type: Interventional

This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer. 100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1. Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727. Others endpoints: biomarkers and pharmacogenetics analysis (optional)