NCT00261196

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

November 30, 2005

Last Update Submit

October 1, 2019

Conditions

Adhesive CapsulitisFrozen Shoulder

Keywords

Frozen Shoulder

Outcome Measures

Primary Outcomes (1)

  • Active elevation of the affected shoulder

    Active Elevation in degrees by goniometer measurement

    30 days

Secondary Outcomes (1)

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

    30 days

Study Arms (2)

Collagenase

EXPERIMENTAL

Collagenase Injection

Drug: Collagenase

Placebo

PLACEBO COMPARATOR

Placebo Injection

Drug: Collagenase

Interventions

CollagenaseDRUG

Anterior shoulder capsule injection

Also known as: Xiaflex
CollagenasePlacebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of frozen shoulder of at least one month duration

You may not qualify if:

  • shoulder arthritis
  • rotator cuff tears
  • any chronic, serious, uncontrolled medical condition
  • inability to conform to study visits (20-30 per year)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Orthopaedics, SUNY@Stony Brook

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Bursitis

Interventions

CollagenasesMicrobial Collagenase

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteases

Study Officials

  • Marie A Badalamente, PhD

    Dept. Orthopaedics, SUNY@Stony Brook, NY 11794

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Orthopaedics

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 2, 2005

Study Start

January 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

October 3, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)