There have been many inquiries in the forum regarding the progress of the Phase III Collagenase trials. According to the U.S. National Institutes of Health ClinicalTrials.gov website, the Phase III trials are still not at the point of starting recruitment after almost a year of Phase II completion and the FDA's approval to proceed.

I contacted one of the principal researchers involved with the DP clinical trials and asked about the status of the Phase III trials and also inquired about the reasons for the delay. I received the following response:


"The FDA required a complete redesign of the proposed Phase 3 protocol, that is, the way the trials are to be conducted.
The FDA also required a complete chemical characterization of the drug for Phase 3 studies.
These were intensely time consuming tasks for the investigators and took a very long time to do.
The FDA has also taken a very long time to review these submissions.
The FDA has recently been in touch with us about additional protocol changes and pending our submission of
those, we hope to start Phase 3 trials in the winter of 2003.

RECRUITMENT IS CLOSED AND PATIENT ENROLLMENT IS CLOSED AT ALL FOUR TEST CENTERS.

Please DO NOT lobby the FDA. It would be counterproductive. The only way for the FDA to approve this treatment
is to allow us to do well controlled, scientifically accurate trials which will stand the test of FDA review."


Personally, I cannot see how lobbying the FDA could negatively impact the progress of the trials. There are many DP afflicted people who are trying to make treatment decisions based on the FDA's responsiveness and cooperation in approving the collagenase therapy. I was advised that if any patients in the forum are requiring surgery (or other form of treatment), you should have it and not wait for FDA approval in that approval may still be years away.

What are your thoughts about taking a more aggressive approach in lobbying the FDA in an attempt to accelerate the approval process? Could such a move be counterproductive?

Hope this helps, Mike

Jerry, you made my day. It's about time some humor was interjected into this forum.

I was interviewed at Stanford a couple weeks ago by Dr. Hentz about Stage III trials. At that time, I was told I should hear something within 60 days about the start of the trials.

I found out today that I have this disease and am wondering if the disease can be slowed down. I am not sure what to do but I have decided to wait to have the operation. My finger is not bending at this time but I have had rapid growth since November.

Thank you for any help
Pamela

For the latest on clinical trials, go to http://www.clinicaltrials.gov and type in Dupuytren to find the status and information about this very slow moving investigation.