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Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

This study has been withdrawn prior to enrollment.
(IND moved to sponsor.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00261196
First Posted: December 2, 2005
Last Update Posted: August 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biospecifics Technologies Corp.
Information provided by:
Stony Brook University
  Purpose
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
Intervention Model: Single Group Assignment
Masking: Double
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261196


Locations
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.
Investigators
Principal Investigator: Marie A Badalamente, PhD Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
  More Information

ClinicalTrials.gov Identifier: NCT00261196     History of Changes
Other Study ID Numbers: Shoulder 202
First Submitted: November 30, 2005
First Posted: December 2, 2005
Last Update Posted: August 12, 2011
Last Verified: August 2011

Keywords provided by Stony Brook University:
Frozen Shoulder

Additional relevant MeSH terms:
Bursitis
Joint Diseases
Musculoskeletal Diseases