Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02006719
• Date of registration: 02/12/2013
• Prospective Registration: No
• Primary sponsor: Endo Pharmaceuticals
• Public title: Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder AC
• 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
• Date of first enrolment: November 2013
• Target sample size: 322
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02006719
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, United States

Contacts

• Name: Neil H Schusterman, MD FACP
• Affiliation: Endo Pharmaceuticals

Key inclusion & exclusion criteria

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

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Adhesive Capsulitis

Frozen Shoulder

Intervention(s)

Biological: Collagenase Clostridium Histolyticum

Other: Placebo

Primary Outcome(s)

Change From Baseline to Day 95 in Active Forward Flexion [Time Frame: Baseline, day 95]

Secondary Outcome(s)

Change From Baseline to Day 95 in Active Abduction [Time Frame: Baseline, day 95]

Investigator Assessment of Improvement With Treatment at Day 95 [Time Frame: Day 95]

Change From Baseline to Day 95 in Adapted American Shoulder and Elbow Surgeons (ASES) Function Subscale [Time Frame: Baseline, day 95]

Change From Baseline to Day 95 in Active Internal Rotation [Time Frame: Baseline, day 95]

Change From Baseline to Day 95 in Passive Abduction [Time Frame: Baseline, day 95]

Change From Baseline to Day 95 in Adapted ASES Pain Subscale [Time Frame: Baseline, day 95]

Change From Baseline to Day 95 in Pain With Movement Using 11-point Numeric Rating Scale (NRS) [Time Frame: Baseline, day 95]

Change From Baseline to Day 95 in Active External Rotation [Time Frame: Baseline, day 95]

Change From Baseline to Day 95 in Passive Internal Rotation [Time Frame: Baseline, day 95]

Change From Baseline to Day 95 in Passive External Rotation [Time Frame: Baseline, day 95]

Change From Baseline to Day 95 in Passive Forward Flexion [Time Frame: Baseline, day 95]

Subject Satisfaction With Treatment at Day 95 [Time Frame: Day 95]

Secondary ID(s)

AUX-CC-871

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02006719