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NCT ID: NCT00356915 Completed - Clinical trials for Onychomycosis, Toenail Onychomychosis, Toenail Fungus.

Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.

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

Onychomycosis is a common condition accounting for approximately half of all nail disorders. It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment of onychomycosis in the United States with an approved dosage regimen for the treatment of onychomycosis of the toenail of once daily (QD) treatment with 200mg of itraconazole (two 100 mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200 mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.

NCT ID: NCT00352053 Completed - HIV Infections Clinical Trials

Safety and Efficacy of Tenofovir DF in HIV-1 Infected Adolescents Failing Their Current Antiretroviral Therapy

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

The purpose of this study is to assess the safety and efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) plus a genotype-guided optimized background regimen (OBR) compared to placebo plus OBR in the treatment of human immunodeficiency virus type 1 (HIV-1) infected antiretroviral treatment-experienced adolescents with plasma HIV-1 ribonucleic acid (RNA) levels greater than or equal to 1000 copies/mL.

NCT ID: NCT00346216 Completed - Clinical trials for Arthritis, Rheumatoid

Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

PRECISION
Start date: October 4, 2006
Phase: Phase 4
Study type: Interventional

To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.

NCT ID: NCT00333775 Completed - Breast Cancer Clinical Trials

A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer

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

This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

NCT ID: NCT00316706 Completed - Clinical trials for Cervical Intraepithelial Neoplasia

Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine

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

This protocol posting deals with objectives & outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA). The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924). During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the primary study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00315042 Terminated - Tonsillitis Clinical Trials

TELI TON - Telithromycin in Tonsillitis

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

This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.

NCT ID: NCT00315003 Terminated - Clinical trials for Otitis Media, Suppurative

TELI COM - Telithromycin in Children With Otitis Media

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

This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and <72 months [< 6 years of age]) with AOM.Subjects will be randomized to receive either telithromycin (50 mg/mL) oral suspension 25 mg/kgonce daily for 5 days or azithromycin (40 mg/mL) oral suspension (10 mg/kg once on Day 1, followed by 5 mg/kg once daily on Days 2-5, not to exceed 500 mg onDay 1 and 250 mg/day from Days 2 - 5. Matching placebo suspensions for telithromycin and azithromycin will also be dispensed to provide blinding for the different treatment regimens.Assessments and reporting of safety will be carried out at all visits.

NCT ID: NCT00272779 Completed - HIV Infections Clinical Trials

BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada

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

The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms.

NCT ID: NCT00262067 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)

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

This is a Phase III, multicenter, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy compared with chemotherapy alone in subjects with previously untreated metastatic breast cancer.

NCT ID: NCT00258557 Completed - HIV Clinical Trials

TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.

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

The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with anti-retroviral medications (referred to as "treatment-naïve" patients).