The Phase III trial weas announced in April of 2001. (http://www.clinicaltrials.gov/ct/show/NCT00014742?order=2) I got in touch with the lead researcher last summer and could get no clear answer about when and if the trial would begin.

I've followed the situation with Collagenase for, oh, must be 8 years by now. If I had a contracture heading into stage 3 I wouldn't waste any time even talking to BSTC about trials, I'd be getting a needle aponevrotomy treatment as soon as possible.

Collagenase probably offers little if any advantage over NA, and will be available years from now, if ever. While it may be to Biospecifics' advantage to have patients lined up and waiting for years for a Phase III trial, I see no benefit whatsoever to those patients, with NA available today.

Collagenase in the Treatment of Dupuytrens Disease

This study is not yet open for patient recruitment.
Verified by Stony Brook University November 2005

Sponsors and Collaborators: Stony Brook University
Biospecifics Technologies Corp., Lynbrook, NY
Information provided by: Stony Brook University
ClinicalTrials.gov Identifier: NCT00260429


Purpose

The purpose of the study is to determine if collagenase injection(s) will straighten the finger contractures associated with Dupuytren's disease.
Condition Intervention Phase
Dupuytren's Disease With a Minimum 20 Degree Joint Flexion Contracture of One or More Fingers.
Drug: Collagenase
Phase III


MedlinePlus consumer health information


Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Stony Brook University:
Primary Outcomes: Primary outcome measure is reduction of flexion contracture.
Expected Total Enrollment: 232
Study start: June 2006; Expected completion: June 2007
Last follow-up: June 2007; Data entry closure: June 2007

In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to lyse the Dupuytren's cord.

Resultant cord rupture may obviate the need for patients to have surgery to correct the finger flexion contractures of Dupuytren's disease.

Eligibility

Ages Eligible for Study: 18 Years - 85 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:

diagnosis of Dupuytrens disease
minimum 20 degree contracture(s) of the MP and/or PIP joints in any finger excluding the thumb
Exclusion Criteria:

any chronic, serious or uncontrolled medical condition
inability to conform to study visits (20-30 per year)
Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00260429

Marie A Badalamente 631 444 2215 mbadalamente@notes.cc.sunysb.edu
Gail Trocchio 631 444 2215 gtrocchio@notes.cc.sunysb.edu


California
UCLA Medical Center, Los Angeles, California, United States
310-206-6337


Stanford University Medical Center, Palo Alto, California, United States
650-723-3731


Michigan
Ford Institute, Detroit, Michigan, United States
313-916-3879

More Information

Publications

Badalamente MA, Hurst LC, Hentz VR. Collagen as a clinical target: nonoperative treatment of Dupuytren's disease. J Hand Surg [Am]. 2002 Sep;27(5):788-98.

Study ID Numbers: DUPY 303
Last Updated: December 8, 2005
Record first received: November 29, 2005
ClinicalTrials.gov Identifier: NCT00260429
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-02-06

Randy, I would think that you are on the right track. Collagenase probably could do much more than NA, provided its use is safe. It would be great if we had the FDA approval! The upside of the dealy might be that it provides longer term results ...

Wolfgang

This is a response to my inquiry regarding the phase 3 trials :

Postponed until October.

Thank you for your recent inquiry regarding our Dupuytren's disease
clinical research study. This is a clinical study
evaluating the use of a new drug (an enzyme) as a non-operative
injection therapy for Dupuytren's disease. If successful, patients may
avoid surgery for correction of their disease.

The study is being performed at the Dept. Orthopaedics,
State University of New York at Stony Brook (Long Island) and Stanford
University Medical Center, Palo Alto, Califonia and at UCLA Medical Center,
Los Angeles, California. Other clinical test sites may be added but we
have not established the sites as yet. There is an
initial evaluation visit to see if patients meet entry criteria for the
study, if accepted, the next visit is a routine medical physical (blood
work, EKG, chest X ray). The next visit is the injection treatment.
Patients are then seen the next day, weekly for two weeks, monthly for
three months and at six, nine and twelve months, for each joint treated.
The followup visits do not take long, only 15 minutes or so, but are
critically important. More than one injection may be necessary if a
first does not have an effect or if multiple joints in different fingers
are involved. There is no guarantee of a 100% successful outcome,
however, our results to date are very positive. There is no charge for
participating in the study.

If you live a distance from Long Island or Palo Alto, Los Angeles,
it will be a hardship to travel for the many visits necessary.
We do not pay travel expenses.
It may take up to 15-25 visits or more in the first year depending on how many
fingers are affected by the Dupuytrens Disease.
Your own doctor may NOT administer the injection nor perform the followup
evaluations as we are the only hospitals approved by the FDA to administer
this treatment. A new Phase of study will begin in the fourth quarter of 2006.

Patients must have at least a 20 degree contracture to qualify.

Patient enrollment is limited at Stony Brook and may be at the other Centers
as well. You may call 631 444 2215 at Stony Brook or 650 723 3731 at Palo Alto or 310 206 6337
at UCLA or to be placed on a waiting list for the new Phase of study. Enrollment will be limited so
placement on the waiting list does not assure a place in the study.

FDA approval (if obtained) will take several more years. If you have been advised to have
surgery, you may wish to proceed with it, as your disease will most likely get worse if you wait.

Best wishes to all


JD