Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02006719




Registration number
NCT02006719
Ethics application status
Date submitted
2/12/2013
Date registered
10/12/2013
Date last updated
5/10/2017

Titles & IDs
Public title
Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder
Scientific title
A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder
Secondary ID [1] 0 0
AUX-CC-871
Universal Trial Number (UTN)
Trial acronym
AC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adhesive Capsulitis 0 0
Frozen Shoulder 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Collagenase Clostridium Histolyticum
Other interventions - Placebo

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

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


Treatment: Other: Collagenase Clostridium Histolyticum
Treatment of Adhesive Capsulitis

Other interventions: Placebo
Placebo injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Day 95 in Active Forward Flexion
Timepoint [1] 0 0
Baseline, day 95
Secondary outcome [1] 0 0
Change From Baseline to Day 95 in Adapted American Shoulder and Elbow Surgeons (ASES) Function Subscale
Timepoint [1] 0 0
Baseline, day 95
Secondary outcome [2] 0 0
Change From Baseline to Day 95 in Pain With Movement Using 11-point Numeric Rating Scale (NRS)
Timepoint [2] 0 0
Baseline, day 95
Secondary outcome [3] 0 0
Change From Baseline to Day 95 in Active Abduction
Timepoint [3] 0 0
Baseline, day 95
Secondary outcome [4] 0 0
Change From Baseline to Day 95 in Passive Forward Flexion
Timepoint [4] 0 0
Baseline, day 95
Secondary outcome [5] 0 0
Change From Baseline to Day 95 in Passive Abduction
Timepoint [5] 0 0
Baseline, day 95
Secondary outcome [6] 0 0
Change From Baseline to Day 95 in Active Internal Rotation
Timepoint [6] 0 0
Baseline, day 95
Secondary outcome [7] 0 0
Change From Baseline to Day 95 in Active External Rotation
Timepoint [7] 0 0
Baseline, day 95
Secondary outcome [8] 0 0
Change From Baseline to Day 95 in Passive Internal Rotation
Timepoint [8] 0 0
Baseline, day 95
Secondary outcome [9] 0 0
Change From Baseline to Day 95 in Passive External Rotation
Timepoint [9] 0 0
Baseline, day 95
Secondary outcome [10] 0 0
Change From Baseline to Day 95 in Adapted ASES Pain Subscale
Timepoint [10] 0 0
Baseline, day 95
Secondary outcome [11] 0 0
Subject Satisfaction With Treatment at Day 95
Timepoint [11] 0 0
Day 95
Secondary outcome [12] 0 0
Investigator Assessment of Improvement With Treatment at Day 95
Timepoint [12] 0 0
Day 95

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* Uncontrolled diabetes
* Uncontrolled thyroid disease
* History of thrombosis or post-thrombosis syndrome
* Physical impairment that would preclude performing the protocol defined exercises
* Active infection in area to be treated
* Clinically significant neurological disease
* Bleeding disorder
* Chronic use of anticoagulation medications and the subject cannot be cleared medically to stop taking medication for 7 days prior to each injection. Less than or equal to 150 mg aspirin is allowed during the study.
* Known active hepatitis A, B, or C
* Other significant medical condition (eg, morbid obesity, cervical disc disease), which in the investigator's opinion would make the subject unsuitable for enrollment in the study
* Has received oral or intravenous steroids for any reason within 3 weeks before the screening visit
* Has received an investigational drug or treatment within 30 days before the first dose of study drug.
* Has a known allergy to collagenase or any other excipient of AA4500 or any other procedural medication.
* Has, at any time, received collagenase for the treatment of adhesive capsulitis.
* Is unable to undergo an x-ray or MRI (contraindication) evaluation of the affected shoulder.
* Is planning to be treated with commercial XIAFLEX at any time during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
322
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Sports Medicine Professionals - Richmond
Recruitment hospital [2] 0 0
Hunter Clinical Research - NSW
Recruitment hospital [3] 0 0
Royal Prince Alfred - NSW
Recruitment hospital [4] 0 0
St George Hospital - NSW
Recruitment hospital [5] 0 0
Peninsula Private Hospital - Queensland
Recruitment hospital [6] 0 0
QPharm - Queensland
Recruitment hospital [7] 0 0
Menzies Research Institute - Tasmania
Recruitment hospital [8] 0 0
Emeritus Research - VIC
Recruitment hospital [9] 0 0
Epworth Hospital - VIC
Recruitment hospital [10] 0 0
Repatriation Hospital - VIC
Recruitment hospital [11] 0 0
Hand and Upper Limb Centre - WA
Recruitment postcode(s) [1] 0 0
3121 - Richmond
Recruitment postcode(s) [2] 0 0
- NSW
Recruitment postcode(s) [3] 0 0
- Queensland
Recruitment postcode(s) [4] 0 0
- Tasmania
Recruitment postcode(s) [5] 0 0
- VIC
Recruitment postcode(s) [6] 0 0
- WA
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Endo Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neil H Schusterman, MD FACP
Address 0 0
Endo Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02006719