There are about 10460 clinical studies being (or have been) conducted in Australia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This compassionate use protocol provides expanded access for investigational use of PV-10 in cancer patients who are not eligible for an existing PV-10 clinical trial, for whom there is no comparable or satisfactory approved alternative therapy and whom, in the opinion of the investigator, may benefit from PV-10 administration.
This is a research study into the effects of three drugs used to treat HIV infection. Some drugs used to treat HIV have been associated with changes in blood fats such as cholesterol that could be harmful over the long-term, because these blood fat changes have been associated with a small, increased risk of heart disease and stroke in some studies of adults with HIV. Now that HIV can be controlled for long periods in most patients, and because heart disease is one of the biggest causes of illness and death in the general population, it is important to develop new HIV treatments that control HIV effectively but do not cause abnormal blood fats. Hypothesis: That Raltegravir will result in less post-prandial lipid disturbances than ritonavir-boosted darunavir.
The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD).
The purpose of this study is to determine how much drug is absorbed throughout the body after being applied to the skin.
To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.
This is a study to assess long-term safety and efficacy of lersivirine in patients who have completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.
The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or after docetaxel and to document the overall safety of cabazitaxel in these patients. Please note that in each country, patient recruitment will end when cabazitaxel becomes commercially available.
This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase
This study will be an open-label, randomized, single dose, two-period crossover study to determine the bioavailability of a fixed dose combination capsule formulation of dutasteride and tamsulosin hydrochloride (0.5mg/0.2mg) relative to co-administration of dutasteride 0.5mg capsules and tamsulosin hydrochloride 0.2mg tablets in healthy male subjects of North East Asian and non-Asian ancestry. Subjects will receive single oral doses of a combination capsule formulation of dutasteride 0.5 mg/ tamsulosin 0.2 mg in a fed or fasted state or concomitant dosing of dutasteride 0.5 mg and the Japan-sourced Harnal-D 0.2 mg in a fed or fasted state. Each dose of study medication will be separated by a 28-day washout period. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate, safety laboratory data, and review of adverse events. The study will enrol 88 healthy male subjects to ensure that 80 complete the study. At least twenty percent of the study population will be of Japanese ancestry, approximately 20% will be of Chinese ancestry and approximately 20% of Korean ancestry while the remainder of the population will be of non-Asian ancestry.
Chronic Obstructive Pulmonary Disease (COPD) is a major health concern, with a substantial impact on a patient's life. However, the impact of COPD is currently under-recognised and, as a result, COPD is under-treated. An exacerbation of COPD is a major element that causes poor quality of life and loss of productivity. Therefore, minimizing the frequency of exacerbations is a short term treatment goal in COPD management and could improve Quality of Life (QoL) significantly in all severity groups of COPD. Although the use of spirometry for the determination of disease severity in COPD is supported by guidelines, a lung function test alone does not provide a measurement of the overall impact of COPD on health status and is not generally available especially in primary care centre. Therefore, a standardised and effective dialogue between patients and physicians in a consultation could address the impact of COPD on a patient's QoL in this situation. The COPD Assessment Test (CAT), recently launched in 2009, is a short and simple, self-administered questionnaire designed to assess the condition of patients and overall impact of COPD, and to improve patient-physician communication. It has been proven that the CAT has good repeatability and discriminative properties which suggest that it is sensitive to treatment effects at a group level. The CAT score with its better ability to assess the impact of COPD on patients, suggests potential to predict a significant change in COPD status such as acute exacerbations of COPD. Since the CAT is designed to assess the impact of COPD on the patient by measuring overall impairment, it has better correlations with other instruments, such as the Clinical COPD Questionnaire (CCQ), MRC (Medical Research Council) dyspnoea scale, St George's Respiratory Questionnaire (SGRQ),and the 6-minute walk test. However, it does not correlate well with FEV1 (Forced Expiratory Volume in One Second). While the CAT shares some similarities with other questionnaires, there are several important differences. For example, the SGRQ is substantially longer than the CAT, is complex to administer and requires the use of a computer for scoring. The CAT is designed to provide a holistic measure of the impact of COPD on the patient, whereas the MRC dyspnoea scale only measures dyspnoea, and the CCQ only assesses clinical disease control. Thus, the CAT is the only validated, short and simple assessment test which can provide a holistic measure of the impact of COPD on patients, ensuring both the physicians and the patients gain the understanding needed to manage COPD optimally. QoL is defined as an individual's perception of their position in their life in the context of the culture and value systems. Therefore, the extent of understanding of the questionnaire might be influenced by language and ethnicities. Since the validation findings so far have been based on data from the US and Europe, PACE may provide better quality of data across ethnic groups given that mainly Asian subjects will participate in this study. PACE is designed to evaluate whether the CAT has a high predictive value in detecting subsequent exacerbations of COPD. If so, this result might enable both patients and physicians to better target and optimise management. The primary objective is to evaluate the predictability of the CAT to have subsequent exacerbations in COPD patients. Secondary objectives are to evaluate the predictability of the CAT to have moderate to severe exacerbations or time to the first exacerbation, to identify risk predictors for COPD exacerbations, and to evaluate correlations between CAT scores and FEV1 values, or MRC dyspnea scores. An experimental objective is to evaluate the correlation between the CAT score between 2 consecutive follow-ups (e.g. Week 8 & baseline, Week 16 & Week 8) and a COPD exacerbation over the following treatment period adjusting for demographics, MRC scores, lung function parameters, medical history, and therapy history. PACE is a multicentre, prospective, observational study designed to evaluate the predictability of the CAT score to have COPD exacerbations over 24 weeks. During the study, subjects continue taking their regular prescribed treatment. Investigators are free to make medication adjustments where required. Eligible subjects will have a clinic visit every 8 weeks, during which they will complete the CAT questionnaire, the Exacerbation Check List (ECL), MRC dyspnea scale, and spirometry. A regular phone call is placed every 8 weeks in between clinic visits to collect data for the ECL.There is no follow-up period. 550 male and female outpatient subjects will be recruited for PACE to obtain approximately 300 exacerbation events. This study will capture the winter periods in Australia, China, Korea and Taiwan, when incidence of exacerbations is at its peak. Statistical analysis will be performed on subjects' data to derive the PACE end-points.