Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

This study has been withdrawn prior to enrollment.
(IND moved to sponsor.)
Sponsor:
Collaborator:
Biospecifics Technologies Corp.
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00261196
First received: November 30, 2005
Last updated: August 11, 2011
Last verified: August 2011
  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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:
Bursitis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 01, 2014