AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder
2017年9月7日 更新者：Endo Pharmaceuticals
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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
50
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35209
- Alabama Orthopaedic Center - Research
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Arizona
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Phoenix、Arizona、アメリカ、85050
- Hope Research Institute
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Tucson、Arizona、アメリカ、85712
- Tucson Orthopaedic Institute
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Arkansas
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Little Rock、Arkansas、アメリカ、72205
- OrthoArkansas
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California
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Encinitas、California、アメリカ、92024
- CORE Orthopaedic Medical Center
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La Mesa、California、アメリカ、91942
- TriWest Research Associates
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Florida
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Pinellas Park、Florida、アメリカ、33781
- Advent Clinical Research
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Illinois
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Rockford、Illinois、アメリカ、61107
- Rockford Orthopedic Associates
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Indiana
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Indianapolis、Indiana、アメリカ、46260
- The Indiana Hand to Shoulder Center
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New York
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Stony Brook、New York、アメリカ、11794
- Stony Brook University Medical Center
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Ohio
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Cleveland、Ohio、アメリカ、44143
- David R. Mandel, MD, Inc.
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73109
- Health Research Institute
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Pennsylvania
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Altoona、Pennsylvania、アメリカ、16602
- Blair Orthopedic Associates, Inc.
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Tennessee
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Clarksville、Tennessee、アメリカ、37043
- Alpha Clinical Research, LLC
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Texas
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Odessa、Texas、アメリカ、79761
- Basin Orthopedic Surgical Specialists
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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:
- 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.
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:
- 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
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：AA4500 0.29 mg/1 mL
Up to three injections
|
treatment of adhesive capsulitis
他の名前：
Home shoulder exercises, minimum of 3 times per day
|
|
実験的：AA4500 0.58 mg/2 mL
Up to three injections
|
Home shoulder exercises, minimum of 3 times per day
treatment of adhesive capsulitis
他の名前：
|
|
実験的：AA4500 0.58 mg/1 mL
Up to three injections
|
Home shoulder exercises, minimum of 3 times per day
treatment of adhesive capsulitis
他の名前：
|
|
実験的：AA4500 0.58 mg/0.5 mL
Up to three injections
|
Home shoulder exercises, minimum of 3 times per day
treatment of adhesive capsulitis
他の名前：
|
|
他の：Shoulder exercises
Home shoulder exercises for 64 days
|
Home shoulder exercises, minimum of 3 times per day
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline to Day 92 in Active Forward Flexion
時間枠：Baseline, Day 92
|
Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder
|
Baseline, Day 92
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline to Day 92 in Passive Forward Flexion
時間枠：Baseline, Day 92
|
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
時間枠：Baseline, Day 92
|
AROM measurement using a goniometer to assess abduction in the affected shoulder
|
Baseline, Day 92
|
|
Change From Baseline to Day 92 in Passive Abduction
時間枠：Baseline, Day 92
|
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
時間枠：Baseline, Day 92
|
AROM measurement using a goniometer to assess external rotation in the affected shoulder
|
Baseline, Day 92
|
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Change From Baseline to Day 92 in Passive External Rotation
時間枠：Baseline, Day 92
|
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
時間枠：Baseline, Day 92
|
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
時間枠：Baseline, Day 92
|
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
時間枠：Baseline, Day 92
|
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
時間枠：Baseline, Day 92
|
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
時間枠：Baseline, Day 92
|
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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Neil H Shusterman, MD FACP、Endo Pharmaceuticals
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年11月1日
一次修了 (実際)
2013年2月1日
研究の完了 (実際)
2013年2月1日
試験登録日
最初に提出
2011年11月30日
QC基準を満たした最初の提出物
2011年12月1日
最初の投稿 (見積もり)
2011年12月2日
学習記録の更新
投稿された最後の更新 (実際)
2017年10月5日
QC基準を満たした最後の更新が送信されました
2017年9月7日
最終確認日
2017年9月1日
詳しくは
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