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This study has been withdrawn prior to enrollment.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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 30, 2005

Last Updated Date

August 11, 2011

Start Date ^ICMJE

January 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Active elevation of the affected shoulder

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00261196 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Active and passive shoulder motions in internal/external rotation, passive elevation, pain and function.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

Official Title ^ICMJE

Not Provided

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Adhesive Capsulitis
Frozen Shoulder

Intervention ^ICMJE

Drug: Collagenase

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00261196

Other Study ID Numbers ^ICMJE

Shoulder 202

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Stony Brook University

Collaborators ^ICMJE

Biospecifics Technologies Corp.

Investigators ^ICMJE

Principal Investigator:

Marie A Badalamente, PhD

Dept. Orthopaedics, SUNY@Stony Brook, NY 11794

Information Provided By

Stony Brook University

Verification Date

August 2011

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

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