Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder

NCT02006719 | Completed Phase 2 Results

• 1 other identifier: AUX-CC-871
• Study Type: interventional
• Target: 322
• Locations: 2 countries
• Sites: 46

Brief Summary

The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.

Conditions

Adhesive Capsulitis; Frozen Shoulder

Keywords

Adhesive Capsulitis; Frozen Shoulder; Shoulder Range of Motion limitation; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Day 95 in Active Forward Flexion

  Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder

  Baseline, day 95

Secondary Outcomes (12)

• Change From Baseline to Day 95 in Adapted American Shoulder and Elbow Surgeons (ASES) Function Subscale

  Baseline, day 95

• Change From Baseline to Day 95 in Pain With Movement Using 11-point Numeric Rating Scale (NRS)

  Baseline, day 95

• Change From Baseline to Day 95 in Active Abduction

  Baseline, day 95

• Change From Baseline to Day 95 in Passive Forward Flexion

  Baseline, day 95

• Change From Baseline to Day 95 in Passive Abduction

  Baseline, day 95

Study Arms (2)

Collagenase Clostridium Histolyticum

EXPERIMENTAL

Up to 3 injections of .58 mg/1 mL of collagenase clostridium histolyticum (CCH), minimum of 21 days apart and home shoulder exercise.

Biological: Collagenase Clostridium Histolyticum

Placebo

PLACEBO COMPARATOR

Up to 3 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise.

Other: Placebo

Interventions

Collagenase Clostridium Histolyticum BIOLOGICAL

Treatment of Adhesive Capsulitis

Also known as: AA4500, Xiaflex, Xiapex

Collagenase Clostridium Histolyticum

Placebo OTHER

Placebo injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral idiopathic adhesive capsulitis of one shoulder for at least 3 months but not more than 12 months (Frozen Stage)
• Normal range of motion in the contralateral shoulder
• Restricted active range of motion (AROM) in the affected shoulder defined as: a deficit of at least 60 degrees in total AROM in the affected shoulder as compared with the total AROM in the contralateral shoulder and a deficit of at least 30 degrees in AROM in at least one of the following planes as compared with the contralateral shoulder:
• Forward flexion
• Abduction
• External rotation with the elbow up to 90 degrees abduction
• Internal rotation with the elbow up to 90 degrees abduction

You may not qualify if:

• Has received treatment for adhesive capsulitis or is planning to receive treatment for adhesive capsulitis at any time during the study including but not limited to:
• physical therapy or acupuncture within 2 weeks before the first injection of study drug
• intra-articular or intrabursal injection(s) of lidocaine; suprascapular nerve blocks; corticosteroids, electroanalgesic and/or thermoanalgesic modalities within 1 month before the screening visit
• intra-articular or intrabursal injection(s) of sodium hyaluronate and/or glenohumeral distension arthrography within 3 months before the screening visit
• surgical intervention (including shoulder manipulation under anesthesia) at any time
• Has any of the following conditions, as determined by investigator to be potentially confounding to the evaluation of safety and efficacy:
• Adhesive capsulitis as a result of traumatic injury (ie, direct injury to the shoulder such as fracture of the humerus or clavicle immediately preceding the onset of this episode of adhesive capsulitis). Traumatic events in the past that are not temporally related to the onset of this episode of adhesive capsulitis would not necessarily exclude a subject from participating in the study.
• Active subacromial impingement in the affected shoulder
• Calcified tendonitis in the affected shoulder
• Glenohumeral joint arthritis in the affected shoulder
• Arthrosis of the affected shoulder
• Chondrolysis of the affected shoulder
• Subscapularis tendon rupture of the affected shoulder
• Other rotator cuff injuries of the affected shoulder
• Uncontrolled hypertension

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (46)

Alabama Orthopaedic Center-Research

Birmingham, Alabama, 35209, United States

Location

Coastal Clinical Research

Mobile, Alabama, 36608, United States

Location

Arizona Research Center, Inc.

Phoenix, Arizona, 85023, United States

Location

Advance Med Clinical Research

Carlsbad, California, 92008, United States

Location

Triwest Research Associates

El Cajon, California, 92020, United States

Location

Core Orthopedic Medical Center

Encinitas, California, 92024, United States

Location

Temecula Rheumatology & Internal Medicine

Murrieta, California, 92563, United States

Location

Clearview Medical Research

Santa Clarita, California, 91350, United States

Location

Colorado Orthopedic Consultants, PC

Englewood, Colorado, 80110, United States

Location

Florida Research Associates

DeLand, Florida, 32720, United States

Location

Shrock Orthopedic Research, LLC

Fort Lauderdale, Florida, 33316, United States

Location

Jewett Orthopedic Clinic

Orlando, Florida, 32822, United States

Location

Clinical Research of West Florida

Tampa, Florida, 33603, United States

Location

Non-Surgical Orthopedics, P.C. / Georgia Institute for Clinical Research, LLC

Marietta, Georgia, 30060, United States

Location

Injury Care Medical Center

Boise, Idaho, 83713, United States

Location

Rockford Orthopedic Associates

Rockford, Illinois, 61107, United States

Location

Rockford Orthopedics Associates

Rockford, Illinois, 61114, United States

Location

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

PRN of Kansas

Wichita, Kansas, 67203, United States

Location

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Location

Bone and Joint Clinic

Gretna, Louisiana, 70056, United States

Location

MedPharmics, LLC

Metairie, Louisiana, 70006, United States

Location

Arthritis and Rheumatism Associates, PC

Wheaton, Maryland, 20902, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Nevada Orthopedic & Spine Center

Las Vegas, Nevada, 89128, United States

Location

Stony Brook University Medical Center (SUNY)

Stony Brook, New York, 11794, United States

Location

Triangle Orthopedic Associates, PA

Durham, North Carolina, 27704, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

The Neuromusculoskeletal Center of the Cascades d.b.a. The Center

Bend, Oregon, 97701, United States

Location

Blair Orthopedic Associates, Inc.

Altoona, Pennsylvania, 16602, United States

Location

University of Pennsylvania Penn Orthopaedics

Philadelphia, Pennsylvania, 19087, United States

Location

Texas Orthopedic Specialist

Bedford, Texas, 76021, United States

Location

Centex Studies

Houston, Texas, 77062, United States

Location

Commonwealth Orthopaedics & Rehabilitation

Arlington, Virginia, 22205, United States

Location

Danville Orthopedic Clinic, Inc.

Danville, Virginia, 24541, United States

Location

Sports Medicine Professionals

Richmond, Victoria, 3121, Australia

Location

Hunter Clinical Research

NSW, Australia

Location

Royal Prince Alfred

NSW, Australia

Location

St George Hospital

NSW, Australia

Location

Peninsula Private Hospital

Queensland, Australia

Location

QPharm

Queensland, Australia

Location

Menzies Research Institute

Tasmania, Australia

Location

Emeritus Research

VIC, Australia

Location

Epworth Hospital

VIC, Australia

Location

Repatriation Hospital

VIC, Australia

Location

Hand and Upper Limb Centre

WA, Australia

Location

MeSH Terms

Conditions

Bursitis; Shoulder Pain

Interventions

Microbial Collagenase; xiapex

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals Inc.

clinicalsite.inquiries@endo.com

Study Officials

• Neil H Schusterman, MD FACP

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 10, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 5, 2017
• Results First Posted: May 25, 2017

Record last verified: 2017-09

Locations

US (35); AU (11)