What is the status of FDA clinical trials for collagenase? |
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07/09/2003 23:41
JMondaynot registered
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07/09/2003 23:41
JMondaynot registered
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What is the status of FDA clinical trials for collagenase?
Following surgery (Carpal Tunnel and thumb joint replacement done at same time) on my right hand 1 1/2 yrs ago, DC began to manifest within the six weeks I had a cast on. I have since learned my younger brother has large DC nodule, and my 30 yr. old son has had aggressive onset DC in one hand in last 9 months. I know as a female, outcomes are not usually long-term positive for surgery, and I am want information on the present status (as of July 2003) on the clinical trials for Cordase -- when is the product likely to be available? What would be the criteria for eligibility for treatment -- how severe must one's DC be to get help?
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07/10/2003 23:57
Randy
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07/10/2003 23:57
Randy
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clinical trials
Originally scheduled to begin earlier this year, I have been told that the final Phase III trial of Cordase will begin on the East Coast this month, At Stanford in CA next month and at UCLA the following. Lack of funding is apparently the reason for the delay. I'm told that it is now "good to go". Only candidates for normal surgery will be considered, and must be otherwise healthy. That's the good news.
Now the bad news. Subjects will be closely monitored for two years, and then on a less active basis for another two years. I'm not sure if this means the FDA could approve in two years, or will wait until the end of four. In the mean time, our only option to surgery is a trip to Europe for NA. Now into my third month of recovery for DP surgery, I personally would give the French a crack at it. Surgery recovery will mess with your life unless you are one of the lucky few who say it's "no big deal". Trust me, it's a big deal.
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07/10/2003 23:27
ANON EMUSnot registered
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07/10/2003 23:27
ANON EMUSnot registered
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clinical trials
You said a MOUTHFUL!
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07/11/2003 23:32
wendynot registered
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07/11/2003 23:32
wendynot registered
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clinical trials
hi! while wandering in cyberspace tonite i found a site called clinicaltrials.gov which lists the trial in question along with criteria for patients and contact info... happy surfing! wendy
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