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NCT ID: NCT01087788 Completed - Clinical trials for Arthritis, Psoriatic

Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis

Start date: March 2010
Phase: Phase 3
Study type: Interventional

Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset active and progressive Psoriatic Arthritis (PsA).

NCT ID: NCT01087762 Completed - Clinical trials for Spondyloarthropathies

Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

Start date: March 2010
Phase: Phase 3
Study type: Interventional

The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).

NCT ID: NCT01087151 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Study of ABT-263 in Combination With Dose-Intensive Rituximab, or Dose-Intensive Rituximab Alone, in Previously Untreated Patients With B-Cell, Chronic Lymphocytic Leukemia (CLL)

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

This Phase II, randomized, open-label, international, multicenter trial is designed to evaluate the safety and efficacy of rituximab monotherapy when given according to a dose intense regimen and to assess the safety, efficacy, and pharmacokinetics of ABT-263 when combined with dose-intense rituximab in previously untreated patients with B-cell CLL.

NCT ID: NCT01087099 Completed - Clinical trials for Infections With Soil-Transmitted Helminths (STH)

A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children

WORMCON
Start date: January 2009
Phase: Phase 4
Study type: Interventional

The three major Soil-Transmitted Helminths (STH), Ascaris lumbricoides, Necator americanus/Ancylostoma duodenal and Trichuris trichiura are among the most prevalent parasites worldwide. The objective of this multicentre international study is to define the efficacy of a single 400 milligram dose of albendazole (ALB) against these three STHs using a standardised protocol. The trial will be undertaken among school age children in seven countries - Brazil, Cameroon, Cambodia, Ethiopia, India, Tanzania (Zanzibar) and Vietnam - each with a different epidemiologic pattern of infection. A trial of this nature is urgently required because in spite of the wide usage of albendazole over the last 3 decades, there is still no key publication reporting the efficacy of the anthelmintic accurately, and to modern conventional standards, that can act as a central reference for the baseline efficacy. The latter is critically important because albendazole is now being used even more widely, as large scale mass treatment campaigns are being implemented in Africa and elsewhere, with the intention of reducing morbidity in children. Such large scale usage of a drug risks resistance developing, but resistance cannot be detected unless benchmark values for baseline efficacy are widely known.

NCT ID: NCT01086982 Suspended - Acromegaly Clinical Trials

Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg Compared To Product Sandostatin LAR ®

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

Check the pharmacodynamics of the drug octreotide acetate LAR 30 mg imported and distributed by Chemical Laboratory Pharmaceutical Bergamo Ltda. compared to the drug Sandostatin LAR ® (octreotide acetate 30 mg) manufactured by Novartis Biociências S / A, using as activity analysis of growth hormone (GH) and growth factor insulin-like 1 (IGF-1 ) after a single dose of the drug in patients with acromegaly

NCT ID: NCT01085851 Not yet recruiting - Sunburn Clinical Trials

Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Sunburn Related Symptoms

Start date: n/a
Phase: Phase 3
Study type: Interventional

Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.

NCT ID: NCT01085136 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

LUX-Lung 5: Afatinib Plus Weekly Paclitaxel Versus Investigator's Choice of Single Agent Chemotherapy Following Afatinib Monotherapy in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib

Start date: February 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this randomized, open-label, active-controlled, multi-center trial is to determine the efficacy of BIBW 2992 given as an add-on to chemotherapy in patients with NSCLC Stage IIIb or IV progressing after BIBW 2992 monotherapy compared to chemotherapy alone in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment. Patients enrolled into the trial will be treated and followed until death or lost to follow-up. Additional information on the health-related quality of life (HRQOL) will be collected.

NCT ID: NCT01084447 Completed - Obesity Clinical Trials

Inspiratory Muscle Training After Gastroplasty

Start date: January 2004
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the effect of post-operative inspiratory muscle training on muscle strength and endurance in patients with obesity submitted to gastroplasty.

NCT ID: NCT01084252 Completed - Clinical trials for Hematological Malignancy

Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies

Start date: June 10, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab). Phase 2 (stage 1): To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone. Phase 2 (stage 2): To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm). Secondary Objectives: Phase 1: - To characterize the global safety profile including cumulative toxicities. - To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing schedule(s). - To assess the pharmacodynamics (PD), immune response, and preliminary disease response. Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent: - Safety - Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival. Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex): - Safety - Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival. - Participant-reported changes in health-related quality of life, symptoms of multiple myeloma and generic health status. - Pharmacokinetic profile of Isatuximab. - Immunogenicity of Isatuximab. - Investigate the relationship between CD38 receptor density and CD38 receptor occupancy (Stage 1 only) on multiple myeloma cells and parameters of clinical response.

NCT ID: NCT01084187 Completed - Clinical trials for Erectile Dysfunction

Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

Start date: January 2010
Phase: Phase 4
Study type: Interventional

The purpose of the study is to assess the correlation of FMD of brachial artery and carotid intima media thickness with ED severity and clinical response to vardenafil in hypertensive men.