woblybob
01-24-2005, 09:22 PM
Introduction
we are inviting you to participate in a clinical research study titled "phase two, double-blind, placebo-controlled, multicentre study to assess the efficacy and safety of HP 184 at 100, 200 and 400 mg doses administered orally once daily for 24 weeks in adult patients with chronic spinal cord injury (CSCI)". Aventis Pharma pty Limited is acting as the local Australian sponsor of the study.
This is a clinical research study for new medicine called HP 184. Aventis Pharma proprietor Ltd (aka the sponsor) to develop this new medicine have not decided what HP 184 should be called as it is still in the early stages of research and development. This guard has not been approved by the Food and Drug Administration or the therapeutic goods administration. The FDA in the US and the TGA in Australia are organisations that decide which medicines can be registered for use. The use of HP 184 is therefore experimental. This research study has been approved by Austin health human research ethics committee.
Purpose
the main reason we are doing the research study is to measure the effect of HP 184 on muscle strength by comparing it to placebo (which is tablet that looks like the drug that does not contain any HP 184). We do this by measuring muscle power sensory perception and pain sensation at the beginning of the study and again after 24 weeks of treatment with the study drug HP 184 in patients who have chronic spinal cord injury. For this assessment selected muscles of the body are graded from nought to five.
Some improvement was observed in patients who took the study drug HP 184 for 11 days in the areas of, muscle strength, sensory perception, and pain sensation. However, long-term treatment is required to confirm this is the action of HP 184 and this is why we are asking you to participate in this research study the study drug HP 184 works by preventing the entry of sodium and potassium ions three nerves. This means it improves the functioning of nerves. About 240 chronic spinal cord injury patients between the ages of 18 to 35 will take part in the study of approximately 30 to 35 study centres in Australia, New Zealand, India, America, the UK and Europe. There will be about 10 patients in the study at this hospital. Please take your time to make your decision. Discuss with your family and friends. It is important that you read and understand several general principles apply to all the take part in our studies. Participation in the study is entirely voluntary, you are not obliged to take part. You treatment and the attitude of your doctor towards you will not be affected should you decide not to take part in the study. If you do not wish to being the study it will not affect any benefits to which you are entitled to. If you decide to take part you will need to sign to say that you have given your consent to participate. If you agree to participate, you may withdraw from the study at any time without affecting any benefits to which you would otherwise be entitled. Although for your own safety it is important to you to informed the study doctor.
There is another eight pages, but it just goes on to say what to expect from the trial, tests that they are going to run during the trial and how they measure them.
The Austin hospital is in charge of the Victorian spinal unit (Australia).
Just thought I would let you'se know, in case anybody was interested or is interested, I would be happy to keep you informed on the trial and how it progresses from my perspective or what I find out about how other people are going.
"If neccessity is the mother of invention,Sci cure is one mother of a neccessity".
we are inviting you to participate in a clinical research study titled "phase two, double-blind, placebo-controlled, multicentre study to assess the efficacy and safety of HP 184 at 100, 200 and 400 mg doses administered orally once daily for 24 weeks in adult patients with chronic spinal cord injury (CSCI)". Aventis Pharma pty Limited is acting as the local Australian sponsor of the study.
This is a clinical research study for new medicine called HP 184. Aventis Pharma proprietor Ltd (aka the sponsor) to develop this new medicine have not decided what HP 184 should be called as it is still in the early stages of research and development. This guard has not been approved by the Food and Drug Administration or the therapeutic goods administration. The FDA in the US and the TGA in Australia are organisations that decide which medicines can be registered for use. The use of HP 184 is therefore experimental. This research study has been approved by Austin health human research ethics committee.
Purpose
the main reason we are doing the research study is to measure the effect of HP 184 on muscle strength by comparing it to placebo (which is tablet that looks like the drug that does not contain any HP 184). We do this by measuring muscle power sensory perception and pain sensation at the beginning of the study and again after 24 weeks of treatment with the study drug HP 184 in patients who have chronic spinal cord injury. For this assessment selected muscles of the body are graded from nought to five.
Some improvement was observed in patients who took the study drug HP 184 for 11 days in the areas of, muscle strength, sensory perception, and pain sensation. However, long-term treatment is required to confirm this is the action of HP 184 and this is why we are asking you to participate in this research study the study drug HP 184 works by preventing the entry of sodium and potassium ions three nerves. This means it improves the functioning of nerves. About 240 chronic spinal cord injury patients between the ages of 18 to 35 will take part in the study of approximately 30 to 35 study centres in Australia, New Zealand, India, America, the UK and Europe. There will be about 10 patients in the study at this hospital. Please take your time to make your decision. Discuss with your family and friends. It is important that you read and understand several general principles apply to all the take part in our studies. Participation in the study is entirely voluntary, you are not obliged to take part. You treatment and the attitude of your doctor towards you will not be affected should you decide not to take part in the study. If you do not wish to being the study it will not affect any benefits to which you are entitled to. If you decide to take part you will need to sign to say that you have given your consent to participate. If you agree to participate, you may withdraw from the study at any time without affecting any benefits to which you would otherwise be entitled. Although for your own safety it is important to you to informed the study doctor.
There is another eight pages, but it just goes on to say what to expect from the trial, tests that they are going to run during the trial and how they measure them.
The Austin hospital is in charge of the Victorian spinal unit (Australia).
Just thought I would let you'se know, in case anybody was interested or is interested, I would be happy to keep you informed on the trial and how it progresses from my perspective or what I find out about how other people are going.
"If neccessity is the mother of invention,Sci cure is one mother of a neccessity".