Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

This study has been withdrawn prior to enrollment.
(IND moved to sponsor.)
Biospecifics Technologies Corp.
Information provided by:
Stony Brook University Identifier:
First received: November 30, 2005
Last updated: August 11, 2011
Last verified: August 2011
The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.

Condition Intervention Phase
Adhesive Capsulitis
Frozen Shoulder
Drug: Collagenase
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Active elevation of the affected shoulder

Secondary Outcome Measures:
  • Active and passive shoulder motions in internal/external rotation, passive elevation, pain and function.

Estimated Enrollment: 58
Study Start Date: January 2006
Estimated Study Completion Date: January 2007
Detailed Description:

In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to lyse the adhesions associated with the shoulder capsule in adhesive capsulitis (frozen shoulder).

Treatment success may obviate the need for extensive physical therapy and/or shoulder arthroscopy (surgery) to correct this condition and restore normal and pain free shoulder motion.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diagnosis of frozen shoulder of at least one month duration

Exclusion Criteria:

  • shoulder arthritis
  • rotator cuff tears
  • any chronic, serious, uncontrolled medical condition
  • inability to conform to study visits (20-30 per year)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00261196

United States, New York
Dept. Orthopaedics, SUNY@Stony Brook
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Biospecifics Technologies Corp.
Principal Investigator: Marie A Badalamente, PhD Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
  More Information Identifier: NCT00261196     History of Changes
Other Study ID Numbers: Shoulder 202 
Study First Received: November 30, 2005
Last Updated: August 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Stony Brook University:
Frozen Shoulder

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases processed this record on May 26, 2016