NCT02006719已完成2 期
A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder
Endo Pharmaceuticals82 个研究点 分布在 2 个国家目标入组 322 人开始时间: 2013年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 322
- 试验地点
- 82
- 主要终点
- Change From Baseline to Day 95 in Active Forward Flexion
研究概览
简要总结
The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.
详细描述
Study is a Phase 2b, double-blind, placebo-controlled study of the safety and efficacy 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 28 days before injection of study drug.
Approximately 300 adult women and men are to be enrolled in this study. Following screening and determination of study eligibility, subjects will be randomized 3:1 to receive 0.58 mg of AA4500 or placebo. Subjects will receive up to 3 injections of study drug. Each injection will be separated by a minimum of 21 days. Subjects will also be instructed in home shoulder exercises after the first injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
Up to 3 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise.
干预措施: Placebo (Other)
Collagenase Clostridium Histolyticum
Experimental
Up to 3 injections of .58 mg/1 mL of collagenase clostridium histolyticum (CCH), minimum of 21 days apart and home shoulder exercise.
干预措施: Collagenase Clostridium Histolyticum (Biological)
结局指标
主要结局
Change From Baseline to Day 95 in Active Forward Flexion
时间窗: Baseline, day 95
Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder
次要结局
- Change From Baseline to Day 95 in Adapted American Shoulder and Elbow Surgeons (ASES) Function Subscale(Baseline, day 95)
- Change From Baseline to Day 95 in Pain With Movement Using 11-point Numeric Rating Scale (NRS)(Baseline, day 95)
- Change From Baseline to Day 95 in Active Abduction(Baseline, day 95)
- Change From Baseline to Day 95 in Passive Forward Flexion(Baseline, day 95)
- Change From Baseline to Day 95 in Passive Abduction(Baseline, day 95)
- Change From Baseline to Day 95 in Active Internal Rotation(Baseline, day 95)
- Change From Baseline to Day 95 in Active External Rotation(Baseline, day 95)
- Change From Baseline to Day 95 in Passive Internal Rotation(Baseline, day 95)
- Change From Baseline to Day 95 in Passive External Rotation(Baseline, day 95)
- Change From Baseline to Day 95 in Adapted ASES Pain Subscale(Baseline, day 95)
- Subject Satisfaction With Treatment at Day 95(Day 95)
- Investigator Assessment of Improvement With Treatment at Day 95(Day 95)
研究者
研究点 (82)
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