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The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AA4500 0.29 mg/1 mL | Experimental | Up to three injections |
|
| AA4500 0.58 mg/2 mL | Experimental | Up to three injections |
|
| AA4500 0.58 mg/1 mL | Experimental | Up to three injections |
|
| AA4500 0.58 mg/0.5 mL | Experimental | Up to three injections |
|
| Shoulder exercises | Other | Home shoulder exercises for 64 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AA4500 0.29 mg/1 mL | Biological | treatment of adhesive capsulitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Day 92 |
| Change From Baseline to Day 92 in Active Abduction |
Not provided
Inclusion Criteria:
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:
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.
Exclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Neil H Shusterman, MD FACP | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Orthopaedic Center - Research | Birmingham | Alabama | 35209 | United States | ||
| HOPE Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | AA4500 0.29 mg/1 mL | Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| FG001 | AA4500 0.58 mg/2 mL |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AA4500 0.58 mg/2 mL | Biological | treatment of adhesive capsulitis |
|
|
| AA4500 0.58 mg/1 mL | Biological | treatment of adhesive capsulitis |
|
|
| AA4500 0.58 mg/0.5 mL | Biological | treatment of adhesive capsulitis |
|
|
| Shoulder exercises | Other | Home shoulder exercises, minimum of 3 times per day |
|
AROM measurement using a goniometer to assess abduction in the affected shoulder
| Baseline, Day 92 |
| Change From Baseline to Day 92 in Passive Abduction | PROM measurement using a goniometer to assess abduction in the affected shoulder | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | Day 92 |
| Phoenix |
| Arizona |
| 85050 |
| United States |
| Tucson Orthopaedic Institute | Tucson | Arizona | 85712 | United States |
| OrthoArkansas | Little Rock | Arkansas | 72205 | United States |
| CORE Orthopaedic Medical Center | Encinitas | California | 92024 | United States |
| Triwest Research Associates | La Mesa | California | 91942 | United States |
| Advent Clinical Research | Pinellas Park | Florida | 33781 | United States |
| Rockford Orthopedic Associates | Rockford | Illinois | 61107 | United States |
| The Indiana Hand to Shoulder Center | Indianapolis | Indiana | 46260 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| David R. Mandel, MD, Inc. | Cleveland | Ohio | 44143 | United States |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | United States |
| Blair Orthopedic Associates, Inc. | Altoona | Pennsylvania | 16602 | United States |
| Alpha Clinical Research, LLC | Clarksville | Tennessee | 37043 | United States |
| Basin Orthopedic Surgical Specialists | Odessa | Texas | 79761 | United States |
Up to 3 injections of AA4500 0.58 mg/2 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
| FG002 | AA4500 0.58 mg/1 mL | Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| FG003 | AA4500 0.58 mg/0.5 mL | Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| FG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AA4500 0.29 mg/1 mL | Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| BG001 | AA4500 0.58 mg/2 mL | Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| BG002 | AA4500 0.58 mg/1 mL | Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| BG003 | AA4500 0.58 mg/0.5 mL | Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| BG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group) | Posted | Mean | Standard Deviation | degrees | Baseline, Day 92 |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group) | Posted | Mean | Standard Deviation | degrees | Baseline, Day 92 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 92 in Active Abduction | AROM measurement using a goniometer to assess abduction in the affected shoulder | All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group) | Posted | Mean | Standard Deviation | degrees | Baseline, Day 92 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 92 in Passive Abduction | PROM measurement using a goniometer to assess abduction in the affected shoulder | All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group) | Posted | Mean | Standard Deviation | degrees | Baseline, Day 92 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 92 in Active External Rotation | AROM measurement using a goniometer to assess external rotation in the affected shoulder | All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group) | Posted | Mean | Standard Deviation | degrees | Baseline, Day 92 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 92 in Passive External Rotation | PROM measurement using a goniometer to assess external rotation in the affected shoulder | All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group) | Posted | Mean | Standard Deviation | degrees | Baseline, Day 92 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group) | Posted | Mean | Standard Deviation | degrees | Baseline, Day 92 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group) | Posted | Mean | Standard Deviation | degrees | Baseline, Day 92 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 92 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 92 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 92 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group) | Posted | Count of Participants | Participants | Day 92 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group) | Posted | Count of Participants | Participants | Day 92 |
|
129 days (up to 30 day screening period and 92±7 day study period)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AA4500 0.29 mg/1 mL | Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day | 0 | 10 | 0 | 10 | 9 | 10 |
| EG001 | AA4500 0.58 mg/2 mL | Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day | 0 | 10 | 0 | 10 | 9 | 10 |
| EG002 | AA4500 0.58 mg/1 mL | Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day | 0 | 10 | 0 | 10 | 10 | 10 |
| EG003 | AA4500 0.58 mg/0.5 mL | Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day | 0 | 10 | 0 | 10 | 10 | 10 |
| EG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day | 0 | 10 | 0 | 10 | 2 | 10 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Injection site coldness | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Accident at work | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hypokinesia | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Coordinator | Endo Pharmaceuticals Inc. | clinicalsite.inquiries@endo.com |
| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003012 | Microbial Collagenase |
| C570746 | xiapex |
| ID | Term |
|---|---|
| D017364 | Collagenases |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
| OG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
|
|
| OG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
|
|
| OG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
|
|
Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
| OG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
|
|
Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
| OG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
|
|
Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
| OG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
|
|
Up to 3 injections of AA4500 0.58 mg/0.5 mL
Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
| OG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
|
|
| OG003 | AA4500 0.58 mg/0.5 mL | Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| OG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
|
|
| OG003 | AA4500 0.58 mg/0.5 mL | Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| OG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
|
|
| OG003 | AA4500 0.58 mg/0.5 mL | Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| OG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
|
|
Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| OG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
|
|
| OG003 |
| AA4500 0.58 mg/0.5 mL |
Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
| OG004 | Shoulder Exercises Only | Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day |
|
|