Which clinical trial are you in?

[just1more]

Somewhat off-topic but I was looking at the trial criteria for VX770 and they exclude anyone using HTS.

If VX770 is a oral (tablet) medication, does anyone know why you can't use HTS?

I would understand if VX770 was inhaled; but as a oral drug interacting at the gene level I'm confused how salt water makes a difference.

Just curious...

 

[just1more]

Somewhat off-topic but I was looking at the trial criteria for VX770 and they exclude anyone using HTS.

If VX770 is a oral (tablet) medication, does anyone know why you can't use HTS?

I would understand if VX770 was inhaled; but as a oral drug interacting at the gene level I'm confused how salt water makes a difference.

Just curious...

 

[just1more]

Somewhat off-topic but I was looking at the trial criteria for VX770 and they exclude anyone using HTS.

If VX770 is a oral (tablet) medication, does anyone know why you can't use HTS?

I would understand if VX770 was inhaled; but as a oral drug interacting at the gene level I'm confused how salt water makes a difference.

Just curious...

 

[just1more]

Somewhat off-topic but I was looking at the trial criteria for VX770 and they exclude anyone using HTS.

If VX770 is a oral (tablet) medication, does anyone know why you can't use HTS?

I would understand if VX770 was inhaled; but as a oral drug interacting at the gene level I'm confused how salt water makes a difference.

Just curious...

 

[just1more]

Somewhat off-topic but I was looking at the trial criteria for VX770 and they exclude anyone using HTS.
<br />
<br />If VX770 is a oral (tablet) medication, does anyone know why you can't use HTS?
<br />
<br />I would understand if VX770 was inhaled; but as a oral drug interacting at the gene level I'm confused how salt water makes a difference.
<br />
<br />Just curious...

 

[crystalina0814]

I believe it has something to do with the Vertex is altering your sodium chloride channels- which helps release more sodium into the cells? Anyways, Hypertonic could mess with this because of the direct salt you are adding to your body. I think it may also have something to do with maintaining the balance of electrolytes through this process. I am not positive, but I remember my study nurse mentioning something along these lines. You are also not allowed grapefruit anything-juice, fruit, etc. Hmmmm, I am curious to see final reports down the road that explain all of this in more detail!

 

[crystalina0814]

I believe it has something to do with the Vertex is altering your sodium chloride channels- which helps release more sodium into the cells? Anyways, Hypertonic could mess with this because of the direct salt you are adding to your body. I think it may also have something to do with maintaining the balance of electrolytes through this process. I am not positive, but I remember my study nurse mentioning something along these lines. You are also not allowed grapefruit anything-juice, fruit, etc. Hmmmm, I am curious to see final reports down the road that explain all of this in more detail!

 

[crystalina0814]

I believe it has something to do with the Vertex is altering your sodium chloride channels- which helps release more sodium into the cells? Anyways, Hypertonic could mess with this because of the direct salt you are adding to your body. I think it may also have something to do with maintaining the balance of electrolytes through this process. I am not positive, but I remember my study nurse mentioning something along these lines. You are also not allowed grapefruit anything-juice, fruit, etc. Hmmmm, I am curious to see final reports down the road that explain all of this in more detail!

 

[crystalina0814]

I believe it has something to do with the Vertex is altering your sodium chloride channels- which helps release more sodium into the cells? Anyways, Hypertonic could mess with this because of the direct salt you are adding to your body. I think it may also have something to do with maintaining the balance of electrolytes through this process. I am not positive, but I remember my study nurse mentioning something along these lines. You are also not allowed grapefruit anything-juice, fruit, etc. Hmmmm, I am curious to see final reports down the road that explain all of this in more detail!

 

[crystalina0814]

I believe it has something to do with the Vertex is altering your sodium chloride channels- which helps release more sodium into the cells? Anyways, Hypertonic could mess with this because of the direct salt you are adding to your body. I think it may also have something to do with maintaining the balance of electrolytes through this process. I am not positive, but I remember my study nurse mentioning something along these lines. You are also not allowed grapefruit anything-juice, fruit, etc. Hmmmm, I am curious to see final reports down the road that explain all of this in more detail!

 

[kmaried]

Hi,

I agree with Amy - there is no harm with discussing clinical trial results as long as you are not in violation of a contract you have signed. If everyone talks about how great a drug is, it will not invalidate the results... there has to be a significant difference between placebo and drug results in order for the FDA to consider the drug a success... thus, eliminating the placebo effect (everyone thinking it will work or not work for them because other people have said so).

Also, Amy's right about study results being released prior to FDA approval. Here is just one example for Azli (still not approved)...
<a target=_blank class=ftalternatingbarlinklarge href="http://www.chestjournal.org/content/135/5/1223.abstract
">http://www.chestjournal.org/co...t/135/5/1223.abstract
</a>
In terms of clinical trials I have been in... I was on Azli and loved it. I was on inhaled Cipro, and I'm unsure what I thought of that. I was only on it 30 days though in Phase II - could have been placebo for all I know, plus I did it in the fall which is my worst time of year anyway.

I took a break from clinical trials because I was on too many oral and IV abx before and during my wedding - but I'm ready to get back into it now!! I love participating in them.

Kris

 

[kmaried]

Hi,

I agree with Amy - there is no harm with discussing clinical trial results as long as you are not in violation of a contract you have signed. If everyone talks about how great a drug is, it will not invalidate the results... there has to be a significant difference between placebo and drug results in order for the FDA to consider the drug a success... thus, eliminating the placebo effect (everyone thinking it will work or not work for them because other people have said so).

Also, Amy's right about study results being released prior to FDA approval. Here is just one example for Azli (still not approved)...
<a target=_blank class=ftalternatingbarlinklarge href="http://www.chestjournal.org/content/135/5/1223.abstract
">http://www.chestjournal.org/co...t/135/5/1223.abstract
</a>
In terms of clinical trials I have been in... I was on Azli and loved it. I was on inhaled Cipro, and I'm unsure what I thought of that. I was only on it 30 days though in Phase II - could have been placebo for all I know, plus I did it in the fall which is my worst time of year anyway.

I took a break from clinical trials because I was on too many oral and IV abx before and during my wedding - but I'm ready to get back into it now!! I love participating in them.

Kris

 

[kmaried]

Hi,

I agree with Amy - there is no harm with discussing clinical trial results as long as you are not in violation of a contract you have signed. If everyone talks about how great a drug is, it will not invalidate the results... there has to be a significant difference between placebo and drug results in order for the FDA to consider the drug a success... thus, eliminating the placebo effect (everyone thinking it will work or not work for them because other people have said so).

Also, Amy's right about study results being released prior to FDA approval. Here is just one example for Azli (still not approved)...
<a target=_blank class=ftalternatingbarlinklarge href="http://www.chestjournal.org/content/135/5/1223.abstract
">http://www.chestjournal.org/co...t/135/5/1223.abstract
</a>
In terms of clinical trials I have been in... I was on Azli and loved it. I was on inhaled Cipro, and I'm unsure what I thought of that. I was only on it 30 days though in Phase II - could have been placebo for all I know, plus I did it in the fall which is my worst time of year anyway.

I took a break from clinical trials because I was on too many oral and IV abx before and during my wedding - but I'm ready to get back into it now!! I love participating in them.

Kris

 

[kmaried]

Hi,

I agree with Amy - there is no harm with discussing clinical trial results as long as you are not in violation of a contract you have signed. If everyone talks about how great a drug is, it will not invalidate the results... there has to be a significant difference between placebo and drug results in order for the FDA to consider the drug a success... thus, eliminating the placebo effect (everyone thinking it will work or not work for them because other people have said so).

Also, Amy's right about study results being released prior to FDA approval. Here is just one example for Azli (still not approved)...
<a target=_blank class=ftalternatingbarlinklarge href="http://www.chestjournal.org/content/135/5/1223.abstract
">http://www.chestjournal.org/co...t/135/5/1223.abstract
</a>
In terms of clinical trials I have been in... I was on Azli and loved it. I was on inhaled Cipro, and I'm unsure what I thought of that. I was only on it 30 days though in Phase II - could have been placebo for all I know, plus I did it in the fall which is my worst time of year anyway.

I took a break from clinical trials because I was on too many oral and IV abx before and during my wedding - but I'm ready to get back into it now!! I love participating in them.

Kris

 

[kmaried]

Hi,
<br />
<br />I agree with Amy - there is no harm with discussing clinical trial results as long as you are not in violation of a contract you have signed. If everyone talks about how great a drug is, it will not invalidate the results... there has to be a significant difference between placebo and drug results in order for the FDA to consider the drug a success... thus, eliminating the placebo effect (everyone thinking it will work or not work for them because other people have said so).
<br />
<br />Also, Amy's right about study results being released prior to FDA approval. Here is just one example for Azli (still not approved)...
<br /><a target=_blank class=ftalternatingbarlinklarge href="http://www.chestjournal.org/content/135/5/1223.abstract
">http://www.chestjournal.org/co...t/135/5/1223.abstract
</a><br />
<br />In terms of clinical trials I have been in... I was on Azli and loved it. I was on inhaled Cipro, and I'm unsure what I thought of that. I was only on it 30 days though in Phase II - could have been placebo for all I know, plus I did it in the fall which is my worst time of year anyway.
<br />
<br />I took a break from clinical trials because I was on too many oral and IV abx before and during my wedding - but I'm ready to get back into it now!! I love participating in them.
<br />
<br />Kris

 

[kmaried]

I thought about this some more and wondered why it is that Vertex had people sign the confidentiality agreement...

Maybe it has less to do with the integrity of the trial results and more to do with the company financials... For example, if I know that a clinical trial is doing great, and the company hasn't released a press release or publication on that yet - so I go buy the stock -- could that be considered insider trading? Maybe vertex is just trying to protect shareholders. That's the only reason I can come up with...

 

[kmaried]

I thought about this some more and wondered why it is that Vertex had people sign the confidentiality agreement...

Maybe it has less to do with the integrity of the trial results and more to do with the company financials... For example, if I know that a clinical trial is doing great, and the company hasn't released a press release or publication on that yet - so I go buy the stock -- could that be considered insider trading? Maybe vertex is just trying to protect shareholders. That's the only reason I can come up with...

 

[kmaried]

I thought about this some more and wondered why it is that Vertex had people sign the confidentiality agreement...

Maybe it has less to do with the integrity of the trial results and more to do with the company financials... For example, if I know that a clinical trial is doing great, and the company hasn't released a press release or publication on that yet - so I go buy the stock -- could that be considered insider trading? Maybe vertex is just trying to protect shareholders. That's the only reason I can come up with...

 

[kmaried]

I thought about this some more and wondered why it is that Vertex had people sign the confidentiality agreement...

Maybe it has less to do with the integrity of the trial results and more to do with the company financials... For example, if I know that a clinical trial is doing great, and the company hasn't released a press release or publication on that yet - so I go buy the stock -- could that be considered insider trading? Maybe vertex is just trying to protect shareholders. That's the only reason I can come up with...

 

[kmaried]

I thought about this some more and wondered why it is that Vertex had people sign the confidentiality agreement...
<br />
<br />Maybe it has less to do with the integrity of the trial results and more to do with the company financials... For example, if I know that a clinical trial is doing great, and the company hasn't released a press release or publication on that yet - so I go buy the stock -- could that be considered insider trading? Maybe vertex is just trying to protect shareholders. That's the only reason I can come up with...