Collagenase in the Treatment of Dupuytrens Disease
Condition: Dupuytren's Disease
MeSH terms: Dupuytren Contracture
Intervention: collagenase clostridium histolyticum
Intervention description: Subjects could have received up to three injections of AA4500/placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dupuytren's contracture; fixed flexion contracture

Summary:

      The purpose of the study is to determine if collagenase will reduce the degree of contracture
      in the primary joint in subjects with Dupuytren's disease.

      This study was designed to be part of the larger clinical program, for adult patients with
      Dupuytren's contracture with a palpable cord, where the data from 2 pivotal
      Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were
      evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects were at least 18 years of age, of either sex or any race.

          -  Subjects had residual Dupuytren's disease with a fixed-flexion deformity of the
             finger(s) of at least 20 degrees or greater, caused by a palpable cord.

          -  Subjects had a positive "table-top test" defined as the inability to simultaneously
             place their affected finger(s) and palm flat against a table top.

          -  Subjects must have been willing to participate in and complete the study, and comply
             with its procedures by signing an IRB approved written consent form.

          -  Subjects must have been able to understand and adhere to the visit schedule. They must
             have been able to follow study procedures and instructions, and have agreed to report
             concomitant medications and adverse events accurately and consistently.

          -  Women of childbearing potential must have agreed to use an acceptable method of birth
             control or must have been surgically sterilized (hysterectomy or tubal ligation).
             Women of childbearing age had a urine pregnancy test on Day 0 (day of injection) prior
             to the injection.

        Exclusion Criteria

          -  Women who were nursing or who were pregnant (as evidenced by a positive urine
             pregnancy test at the time of enrollment).

          -  Subjects who had participated in an investigational drug trial within 30 days of
             enrollment in this study.

          -  Subjects who had received surgery for Dupuytren's disease within 30 days of enrollment
             in this study.

          -  Subjects who had a known allergy to AA4500 or any of the inactive ingredients in the
             AA4500 injection.

          -  Subjects who had a known allergy to doxycycline.

          -  Subjects who had a medical condition that would have made them unsuitable for
             enrollment.