Collagenase in the Treatment of Adhesive Capsulitis (Froz... | NCT00261196

Studies
Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

NCT00261196

Sponsor

Stony Brook University

Status

Withdrawn

Last Update Posted

Oct 3, 2019Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Adhesive Capsulitis
Frozen Shoulder

Interventions

Collagenase

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

IND moved to sponsor.

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Nov 30, 2005

First Submission Date that Met QC Criteria

Nov 30, 2005

First Posted Date

Dec 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2019

Last Update Posted Date

Oct 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Collagenase	Experimental	Collagenase Injection	Drug: Collagenase
Placebo	Placebo Comparator	Placebo Injection	Drug: Collagenase

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collagenase	Drug	Anterior shoulder capsule injection	Collagenase Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Active elevation of the affected shoulder	Active Elevation in degrees by goniometer measurement	30 days

Secondary Outcomes

Measure	Description	Time Frame
Active and passive shoulder motions in internal/external rotation, passive elevation, pain and function.	Active and passive internal/external rotation in degrees by goniometer measure	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie A Badalamente, PhD	Dept. Orthopaedics, SUNY@Stony Brook, NY 11794	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. Orthopaedics, SUNY@Stony Brook		Stony Brook	New York	11794	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002062	Bursitis

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017364	Collagenases
D003012	Microbial Collagenase

Ancestor Terms

ID	Term
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided