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This study has been withdrawn prior to enrollment.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

November 30, 2005
August 11, 2011
January 2006
Not Provided
Active elevation of the affected shoulder
Same as current
Complete list of historical versions of study NCT00261196 on ClinicalTrials.gov Archive Site
Active and passive shoulder motions in internal/external rotation, passive elevation, pain and function.
Same as current
Not Provided
Not Provided
 
Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)
Not Provided

The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Adhesive Capsulitis
  • Frozen Shoulder
Drug: Collagenase
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
58
January 2007
Not Provided

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00261196
Shoulder 202
Not Provided
Not Provided
Stony Brook University
Biospecifics Technologies Corp.
Principal Investigator: Marie A Badalamente, PhD Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
Stony Brook University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP