Adhesive CapsulitisPhase 2NCT01483963
AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder
A Phase 2 study testing AA4500 0.29 mg/1 mL, AA4500 0.58 mg/2 mL and AA4500 0.58 mg/1 mL in people with Adhesive Capsulitis and Frozen Shoulder, run by Endo USA Inc., a Keenova Therapeutics Company at 15 sites in United States.
Trial summary
The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis, Frozen Shoulder
- What is being tested?
- AA4500 0.29 mg/1 mL, AA4500 0.58 mg/2 mL and AA4500 0.58 mg/1 mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 15 sitesUnited States
- Study dates
- Nov 2011to Feb 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 34Show fewer
- 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
- 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
- Coagulation disorder, using anticoagulant (except for less than or equal to 150 mg aspirin) within 7 days prior to each injection day
- Known active hepatitis B or C (history of hepatitis A permitted)
- 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
- Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits.
- 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 systemic 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Blair Orthopedic Associates, Inc.
Altoona, Pennsylvania, 16602
Alabama Orthopaedic Center - Research
Birmingham, Alabama, 35209
Alpha Clinical Research, LLC
Clarksville, Tennessee, 37043
David R. Mandel, MD, Inc.
Cleveland, Ohio, 44143
CORE Orthopaedic Medical Center
Encinitas, California, 92024
The Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
Triwest Research Associates
La Mesa, California, 91942
OrthoArkansas
Little Rock, Arkansas, 72205
Basin Orthopedic Surgical Specialists
Odessa, Texas, 79761
Health Research Institute
Oklahoma City, Oklahoma, 73109
HOPE Research Institute
Phoenix, Arizona, 85050
Advent Clinical Research
Pinellas Park, Florida, 33781
Rockford Orthopedic Associates
Rockford, Illinois, 61107
Stony Brook University Medical Center
Stony Brook, New York, 11794
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
About this study
Official title: A Phase 2a, Open-label, Dose-ranging Study of the Safety and Effectiveness of AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder
The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.
Read the detailed description
This study is a Phase 2a, open-label, dose-ranging study of the safety and effectiveness of AA4500 for the treatment of adhesive capsulitis of the shoulder. To be eligible for treatment, a subject must have unilateral idiopathic adhesive capsulitis of the shoulder with restricted range of motion in the affected shoulder for at least 3 months but not more than 12 months. Subjects will be screened for study eligibility within 30 days before injection of study drug.
Approximately 50 adult women and men are to be enrolled in this study. Following screening and determination of study eligibility, Assignment to Cohorts 1-4 is sequential. Subjects assigned to Cohorts 1 through 4 may receive up to 3 injections of AA4500 according to cohort assignment. Each injection will be separated by a minimum of 21 days. Subjects assigned to Cohort 5 will receive home shoulder exercises only, while subjects assigned to Cohorts 1-4 will receive AA4500 and home shoulder exercises. Subjects in Cohort 5 will be offered physical therapy sessions for a period of 2 months following completion of the study.
Dosing will range from 0.29 mg to 0.58 mg with varying volumes.
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Being tested
- AA4500 0.29 mg/1 mL, AA4500 0.58 mg/2 mL, AA4500 0.58 mg/1 mL, AA4500 0.58 mg/0.5 mL, Shoulder exercises
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AA4500 0.29 mg/1 mLBiological
Also called collagenase clostridium histolyticum, XIAFLEX, XIAPEX
treatment of adhesive capsulitis
AA4500 0.58 mg/2 mLBiological
Also called collagenase clostridium histolyticum, XIAFLEX, XIAPEX
treatment of adhesive capsulitis
AA4500 0.58 mg/1 mLBiological
Also called collagenase clostridium histolyticum, XIAFLEX, XIAPEX
treatment of adhesive capsulitis
AA4500 0.58 mg/0.5 mLBiological
Also called collagenase clostridium histolyticum, XIAFLEX, XIAPEX
treatment of adhesive capsulitis
Shoulder exercisesOther
Home shoulder exercises, minimum of 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| AA4500 0.29 mg/1 mL | Experimental | Up to three injections Receives: Biological: AA4500 0.29 mg/1 mL; Other: Shoulder exercises |
| AA4500 0.58 mg/2 mL | Experimental | Up to three injections Receives: Biological: AA4500 0.58 mg/2 mL; Other: Shoulder exercises |
| AA4500 0.58 mg/1 mL | Experimental | Up to three injections Receives: Biological: AA4500 0.58 mg/1 mL; Other: Shoulder exercises |
| AA4500 0.58 mg/0.5 mL | Experimental | Up to three injections Receives: Biological: AA4500 0.58 mg/0.5 mL; Other: Shoulder exercises |
| Shoulder exercises | Other | Home shoulder exercises for 64 days Receives: Other: Shoulder exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Day 92
Secondary outcomes (12)
Change From Baseline to Day 92 in Passive Forward Flexion
Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder
Measured: Baseline, Day 92
Change From Baseline to Day 92 in Active Abduction
AROM measurement using a goniometer to assess abduction in the affected shoulder
Measured: Baseline, Day 92
Change From Baseline to Day 92 in Passive Abduction
PROM measurement using a goniometer to assess abduction in the affected shoulder
Measured: Baseline, Day 92
Change From Baseline to Day 92 in Active External Rotation
AROM measurement using a goniometer to assess external rotation in the affected shoulder
Measured: Baseline, Day 92
Change From Baseline to Day 92 in Passive External Rotation
PROM measurement using a goniometer to assess external rotation in the affected shoulder
Measured: Baseline, Day 92
Change From Baseline to Day 92 in Active Internal Rotation
AROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder
Measured: Baseline, Day 92
Change From Baseline to Day 92 in Passive Internal Rotation
PROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder
Measured: Baseline, Day 92
Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score
Composite score ranging from 0-100, with 0 being worst pain and function loss, derived from the sum of the scores from pain subscale (11-point NRS where 0=no pain at all and 10=pain) and function subscale (activity questionnaire where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation
Measured: Baseline, Day 92
Change From Baseline to Day 92 in ASES Pain Subscale
Pain subscale score ranging from 0-50, with 0 being greatest pain, derived from participant assessment of pain in response to "How bad is the pain in your affected shoulder today?" on an 11-point numerical rating scale (NRS) where 0=no pain at all and 10=pain as bad as it can be and calculated as (10 - NRS score) x 5); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation
Measured: Baseline, Day 92
Change From Baseline to Day 92 in ASES Function Subscale
Function subscale score ranging from 0-50, with 0 being most dysfunctional, derived from participant assessment of ability to do 10 activities with affected shoulder/arm where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult, and calculated as (cumulative total score for the 10 activity items) × (5/3); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation
Measured: Baseline, Day 92
Subject Satisfaction With Treatment at Day 92
Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied.
Measured: Day 92
Investigator Assessment of Improvement With Treatment at Day 92
Investigator assessment of degree of improvement in severity of the participant's treated shoulder compared with screening rated as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
Measured: Day 92
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil H Shusterman, MD FACP, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483963
- Sponsor's protocol ID
- AUX-CC-870
- Status last verified
- Sep 2017
- First submitted
- 30 Nov 2011
- Last updated
- 5 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-label, Dose-ranging Study of the Safety and Effectiveness of AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder
- ClinicalTrials.gov ID
- NCT01483963
- Acronym / sponsor ID
- AUX-CC-870
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Posted 25 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.
Detailed description
This study is a Phase 2a, open-label, dose-ranging study of the safety and effectiveness of AA4500 for the treatment of adhesive capsulitis of the shoulder. To be eligible for treatment, a subject must have unilateral idiopathic adhesive capsulitis of the shoulder with restricted range of motion in the affected shoulder for at least 3 months but not more than 12 months. Subjects will be screened for study eligibility within 30 days before injection of study drug.
Approximately 50 adult women and men are to be enrolled in this study. Following screening and determination of study eligibility, Assignment to Cohorts 1-4 is sequential. Subjects assigned to Cohorts 1 through 4 may receive up to 3 injections of AA4500 according to cohort assignment. Each injection will be separated by a minimum of 21 days. Subjects assigned to Cohort 5 will receive home shoulder exercises only, while subjects assigned to Cohorts 1-4 will receive AA4500 and home shoulder exercises. Subjects in Cohort 5 will be offered physical therapy sessions for a period of 2 months following completion of the study.
Dosing will range from 0.29 mg to 0.58 mg with varying volumes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AA4500 0.29 mg/1 mL | Experimental | Biological: AA4500 0.29 mg/1 mL, Other: Shoulder exercisesUp to three injections |
| AA4500 0.58 mg/2 mL | Experimental | Biological: AA4500 0.58 mg/2 mL, Other: Shoulder exercisesUp to three injections |
| AA4500 0.58 mg/1 mL | Experimental | Biological: AA4500 0.58 mg/1 mL, Other: Shoulder exercisesUp to three injections |
| AA4500 0.58 mg/0.5 mL | Experimental | Biological: AA4500 0.58 mg/0.5 mL, Other: Shoulder exercisesUp to three injections |
| Shoulder exercises | Other | Other: Shoulder exercisesHome shoulder exercises for 64 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (34 listed)
- 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:
- Has any of the following conditions, as determined by the investigator:
- Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AA4500 0.29 mg/1 mLAlso: collagenase clostridium histolyticum, XIAFLEX, XIAPEXtreatment of adhesive capsulitis | Biological | AA4500 0.29 mg/1 mL |
| AA4500 0.58 mg/2 mLAlso: collagenase clostridium histolyticum, XIAFLEX, XIAPEXtreatment of adhesive capsulitis | Biological | AA4500 0.58 mg/2 mL |
| AA4500 0.58 mg/1 mLAlso: collagenase clostridium histolyticum, XIAFLEX, XIAPEXtreatment of adhesive capsulitis | Biological | AA4500 0.58 mg/1 mL |
| AA4500 0.58 mg/0.5 mLAlso: collagenase clostridium histolyticum, XIAFLEX, XIAPEXtreatment of adhesive capsulitis | Biological | AA4500 0.58 mg/0.5 mL |
| Shoulder exercisesHome shoulder exercises, minimum of 3 times per day | Other | 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 |
Primary outcome
Change From Baseline to Day 92 in Active Forward Flexion
Time frame: Baseline, Day 92
Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder
12 secondary outcomes
Change From Baseline to Day 92 in Passive Forward Flexion
Time frame: Baseline, Day 92
Change From Baseline to Day 92 in Active Abduction
Time frame: Baseline, Day 92
Change From Baseline to Day 92 in Passive Abduction
Time frame: Baseline, Day 92
Change From Baseline to Day 92 in Active External Rotation
Time frame: Baseline, Day 92
Change From Baseline to Day 92 in Passive External Rotation
Time frame: Baseline, Day 92
Change From Baseline to Day 92 in Active Internal Rotation
Time frame: Baseline, Day 92
Change From Baseline to Day 92 in Passive Internal Rotation
Time frame: Baseline, Day 92
Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score
Time frame: Baseline, Day 92
Change From Baseline to Day 92 in ASES Pain Subscale
Time frame: Baseline, Day 92
Change From Baseline to Day 92 in ASES Function Subscale
Time frame: Baseline, Day 92
Subject Satisfaction With Treatment at Day 92
Time frame: Day 92
Investigator Assessment of Improvement With Treatment at Day 92
Time frame: Day 92
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil H Shusterman, MD FACP study director
Endo USA Inc., a Keenova Therapeutics Company
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AA4500 0.29 mg/1 mL, AA4500 0.58 mg/2 mL and AA4500 0.58 mg/1 mL in people with Adhesive Capsulitis and Frozen Shoulder, run by Endo USA Inc., a Keenova Therapeutics Company at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Day 92 in Active Forward Flexion (time frame: Baseline, Day 92). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.