AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder
2017년 9월 7일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
50
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35209
- Alabama Orthopaedic Center - Research
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Arizona
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Phoenix, Arizona, 미국, 85050
- HOPE Research Institute
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Tucson, Arizona, 미국, 85712
- Tucson Orthopaedic Institute
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- OrthoArkansas
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California
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Encinitas, California, 미국, 92024
- CORE Orthopaedic Medical Center
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La Mesa, California, 미국, 91942
- TriWest Research Associates
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Florida
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Pinellas Park, Florida, 미국, 33781
- Advent Clinical Research
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Illinois
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Rockford, Illinois, 미국, 61107
- Rockford Orthopedic Associates
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Indiana
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Indianapolis, Indiana, 미국, 46260
- The Indiana Hand to Shoulder Center
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New York
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Stony Brook, New York, 미국, 11794
- Stony Brook University Medical Center
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Ohio
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Cleveland, Ohio, 미국, 44143
- David R. Mandel, MD, Inc.
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73109
- Health Research Institute
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Pennsylvania
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Altoona, Pennsylvania, 미국, 16602
- Blair Orthopedic Associates, Inc.
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Tennessee
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Clarksville, Tennessee, 미국, 37043
- Alpha Clinical Research, LLC
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Texas
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Odessa, Texas, 미국, 79761
- Basin Orthopedic Surgical Specialists
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: AA4500 0.29 mg/1 mL
Up to three injections
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treatment of adhesive capsulitis
다른 이름들:
Home shoulder exercises, minimum of 3 times per day
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실험적: AA4500 0.58 mg/2 mL
Up to three injections
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Home shoulder exercises, minimum of 3 times per day
treatment of adhesive capsulitis
다른 이름들:
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실험적: AA4500 0.58 mg/1 mL
Up to three injections
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Home shoulder exercises, minimum of 3 times per day
treatment of adhesive capsulitis
다른 이름들:
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실험적: AA4500 0.58 mg/0.5 mL
Up to three injections
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Home shoulder exercises, minimum of 3 times per day
treatment of adhesive capsulitis
다른 이름들:
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다른: Shoulder exercises
Home shoulder exercises for 64 days
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Home shoulder exercises, minimum of 3 times per day
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline to Day 92 in Active Forward Flexion
기간: Baseline, Day 92
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Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder
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Baseline, Day 92
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline to Day 92 in Passive Forward Flexion
기간: Baseline, Day 92
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Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder
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Baseline, Day 92
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Change From Baseline to Day 92 in Active Abduction
기간: Baseline, Day 92
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AROM measurement using a goniometer to assess abduction in the affected shoulder
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Baseline, Day 92
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Change From Baseline to Day 92 in Passive Abduction
기간: Baseline, Day 92
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PROM measurement using a goniometer to assess abduction in the affected shoulder
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Baseline, Day 92
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Change From Baseline to Day 92 in Active External Rotation
기간: Baseline, Day 92
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AROM measurement using a goniometer to assess external rotation in the affected shoulder
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Baseline, Day 92
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Change From Baseline to Day 92 in Passive External Rotation
기간: Baseline, Day 92
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PROM measurement using a goniometer to assess external rotation in the affected shoulder
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Baseline, Day 92
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Change From Baseline to Day 92 in Active Internal Rotation
기간: Baseline, Day 92
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AROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder
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Baseline, Day 92
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Change From Baseline to Day 92 in Passive Internal Rotation
기간: Baseline, Day 92
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PROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder
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Baseline, Day 92
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Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score
기간: Baseline, Day 92
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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
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Baseline, Day 92
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Change From Baseline to Day 92 in ASES Pain Subscale
기간: Baseline, Day 92
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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
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Baseline, Day 92
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Change From Baseline to Day 92 in ASES Function Subscale
기간: Baseline, Day 92
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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
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Baseline, Day 92
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Subject Satisfaction With Treatment at Day 92
기간: Day 92
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Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied.
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Day 92
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Investigator Assessment of Improvement With Treatment at Day 92
기간: Day 92
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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.
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Day 92
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Neil H Shusterman, MD FACP, Endo Pharmaceuticals
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 11월 1일
기본 완료 (실제)
2013년 2월 1일
연구 완료 (실제)
2013년 2월 1일
연구 등록 날짜
최초 제출
2011년 11월 30일
QC 기준을 충족하는 최초 제출
2011년 12월 1일
처음 게시됨 (추정)
2011년 12월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 10월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 9월 7일
마지막으로 확인됨
2017년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .