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NCT ID: NCT00975754 Completed - Healthy Volunteers Clinical Trials

Lung Deposition Via Different Inhalation Devices

Start date: September 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the deposition of budesonide to the lung after inhalation with 5 different devices and to relate the findings to in vitro properties of inhaled budesonide.

NCT ID: NCT00975676 Completed - Breast Cancer Clinical Trials

Study of Estrogen Levels in Premenopausal Women Who Have Undergone Surgery for Breast Cancer and Are Receiving Triptorelin and Tamoxifen Citrate or Exemestane on Clinical Trial IBCSG 24-02

SOFT-EST
Start date: November 25, 2008
Phase: N/A
Study type: Interventional

RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane works in lowering estrogen levels. PURPOSE: This clinical trial is studying estrogen levels in premenopausal women who have undergone surgery for breast cancer and are receiving triptorelin and tamoxifen citrate or exemestane on clinical trial IBCSG-2402.

NCT ID: NCT00975442 Completed - Tennis Elbow Clinical Trials

Effects of Eccentric Training for Patients With Lateral Epicondylalgia

Start date: February 2005
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate eccentric training as an intervention for lateral epicondylalgia (tennis elbow) in a clinical setting.

NCT ID: NCT00975286 Completed - Clinical trials for Type 2 Diabetes Mellitus

24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

GetGoal Duo1
Start date: October 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.

NCT ID: NCT00969059 Completed - Pain, Neuropathic Clinical Trials

Study in Neuropathic Pain Patients With Peripheral Nerve Injury

PNI
Start date: August 2009
Phase: Phase 2
Study type: Interventional

This study will be a double-blind, placebo-controlled, parallel group study. After enrolment and initial assessments, subjects will receive oral GW856553 7.5 milligram (mg) twice daily (BID) or matching placebo for 28 days in a 1:1 ratio. Sufficient numbers of subjects will be recruited to obtain 142 evaluable subjects. This is a double-blind, randomized, placebo-controlled, parallel group study. Subjects will undertake a screening period which may last up to approximately 3 weeks, followed by a baseline period of 1 week, a randomized treatment period of 4 weeks and a follow-up period of approximately 2 weeks. This is a multi-centre, double-blind, randomized, placebo-controlled study in subjects who have at least moderate intensity of neuropathic pain resulting from peripheral nerve injury due to trauma or surgery. It will investigate the efficacy, safety and tolerability of GW856553 over 28 days of treatment. Approximately 158 subjects will be randomized to ensure 142 evaluable subjects. Randomization ratio will be 1:1 for placebo or GW856553 respectively. The dose of GW856553 will be 7.5 mg BID.

NCT ID: NCT00968890 Completed - Influenza Clinical Trials

Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly

Start date: September 12, 2009
Phase: Phase 2
Study type: Interventional

The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.

NCT ID: NCT00968708 Completed - Clinical trials for Diabetes Mellitus, Type 2

Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome

EXAMINE
Start date: September 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.

NCT ID: NCT00968045 Completed - Clinical trials for Coronary Artery Disease

Fibrinogen and Bleeding After Cardiac Surgery

Fibro-3
Start date: April 2009
Phase: Phase 2
Study type: Interventional

The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding and transfusion requirements after coronary artery bypass surgery (CABG) in patients with endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a prospective, randomized double-blind placebo-controlled single center study.

NCT ID: NCT00967707 Completed - Clinical trials for Post-traumatic Neuropathic Pain

Population Pharmacokinetic-pharmacodynamic (PK-PD) Modeling of Co-administered Gabapentin in Neuropathic Pain

Start date: August 2009
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to develop a pharmacokinetic (PK) and a pharmacokinetic-pharmacodynamic (PK-PD) model for gabapentin in patients with neuropathic pain. The secondary objectives are to investigate whether adjuvant therapy of venlafaxine or donepezil contributes to 1) improved analgesic efficacy and 2) improved health-related quality of life (assessed by the SF-36 questionnaire) in neuropathic pain patients treated with gabapentin.

NCT ID: NCT00967018 Completed - Prostate Cancer Clinical Trials

A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

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

Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.