AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder

NCT01483963 | Completed Phase 2 Results

• 1 other identifier: AUX-CC-870
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 15

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Day 92 in Active Forward Flexion

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

  Baseline, Day 92

Secondary Outcomes (12)

• Change From Baseline to Day 92 in Passive Forward Flexion

  Baseline, Day 92

• Change From Baseline to Day 92 in Active Abduction

  Baseline, Day 92

• Change From Baseline to Day 92 in Passive Abduction

  Baseline, Day 92

• Change From Baseline to Day 92 in Active External Rotation

  Baseline, Day 92

• Change From Baseline to Day 92 in Passive External Rotation

  Baseline, Day 92

Study Arms (5)

AA4500 0.29 mg/1 mL

EXPERIMENTAL

Up to three injections

Biological: AA4500 0.29 mg/1 mL; Other: Shoulder exercises

AA4500 0.58 mg/2 mL

EXPERIMENTAL

Up to three injections

Biological: AA4500 0.58 mg/2 mL; Other: Shoulder exercises

AA4500 0.58 mg/1 mL

EXPERIMENTAL

Up to three injections

Biological: AA4500 0.58 mg/1 mL; Other: Shoulder exercises

AA4500 0.58 mg/0.5 mL

EXPERIMENTAL

Up to three injections

Biological: AA4500 0.58 mg/0.5 mL; Other: Shoulder exercises

Shoulder exercises

OTHER

Home shoulder exercises for 64 days

Other: Shoulder exercises

Interventions

AA4500 0.29 mg/1 mL BIOLOGICAL

treatment of adhesive capsulitis

Also known as: collagenase clostridium histolyticum, XIAFLEX, XIAPEX

AA4500 0.29 mg/1 mL

AA4500 0.58 mg/2 mL BIOLOGICAL

treatment of adhesive capsulitis

Also known as: collagenase clostridium histolyticum, XIAFLEX, XIAPEX

AA4500 0.58 mg/2 mL

AA4500 0.58 mg/1 mL BIOLOGICAL

treatment of adhesive capsulitis

Also known as: collagenase clostridium histolyticum, XIAFLEX, XIAPEX

AA4500 0.58 mg/1 mL

AA4500 0.58 mg/0.5 mL BIOLOGICAL

treatment of adhesive capsulitis

Also known as: collagenase clostridium histolyticum, XIAFLEX, XIAPEX

AA4500 0.58 mg/0.5 mL

Shoulder exercises OTHER

Home shoulder exercises, minimum of 3 times per day

AA4500 0.29 mg/1 mL; AA4500 0.58 mg/0.5 mL; AA4500 0.58 mg/1 mL; AA4500 0.58 mg/2 mL; Shoulder exercises

Eligibility Criteria

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

You may qualify if:

• Be a male or female and be greater than or equal to 18 years of age
• If a female of childbearing potential, have a negative urine pregnancy test and be using an effective contraception method (ie, abstinence, intrauterine device (IUD), hormonal (estrogen/progestin) contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for one menstrual cycle following end of study, or be surgically sterile
• Have unilateral idiopathic adhesive capsulitis of one shoulder for at least 3 months but not more than 12 months before the screening visit and be in Stage 2 (frozen or adhesive stage), as determined by the investigator
• Have normal range of motion in the contralateral shoulder, as determined by the investigator
• Have 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
• Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution.
• Be able to complete and understand the various rating instruments in English.

You may not qualify if:

• Is a pregnant or lactating female or female intending to become pregnant during the study
• Is a male who intends to father a child during the study
• 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 AA4500
• 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 within 3 months before the screening visit
• glenohumeral distension arthrography and/or surgical intervention (including shoulder manipulation under anesthesia) at any time
• Has any of the following conditions, as determined by the investigator:
• Adhesive capsulitis as a result of traumatic injury
• Pain in the affected shoulder at rest that is greater than or equal to 4 on the 11-point pain scale
• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (15)

Alabama Orthopaedic Center - Research

Birmingham, Alabama, 35209, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85050, United States

Location

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

OrthoArkansas

Little Rock, Arkansas, 72205, United States

Location

CORE Orthopaedic Medical Center

Encinitas, California, 92024, United States

Location

Triwest Research Associates

La Mesa, California, 91942, United States

Location

Advent Clinical Research

Pinellas Park, Florida, 33781, United States

Location

Rockford Orthopedic Associates

Rockford, Illinois, 61107, United States

Location

The Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

David R. Mandel, MD, Inc.

Cleveland, Ohio, 44143, United States

Location

Health Research Institute

Oklahoma City, Oklahoma, 73109, United States

Location

Blair Orthopedic Associates, Inc.

Altoona, Pennsylvania, 16602, United States

Location

Alpha Clinical Research, LLC

Clarksville, Tennessee, 37043, United States

Location

Basin Orthopedic Surgical Specialists

Odessa, Texas, 79761, United States

Location

MeSH Terms

Conditions

Bursitis

Interventions

Microbial Collagenase; xiapex

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

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 Shusterman, 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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 2, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 5, 2017
• Results First Posted: May 25, 2017

Record last verified: 2017-09

Locations

US (15)