NCT00936559终止1 期
Randomized, Single-Blind, Standard Of Care Control, Dose-Escalating, Multicenter, Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Full Thickness Rotator Cuff Tears Treated By Means Of An Open Surgical Procedure
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Abnormal X-rays, MRIs, CT scans, physical examination of limb, functional evaluations, AE/SAE, vital signs, subject assessment of pain, lab tests
研究概览
简要总结
Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).
详细描述
This decision to terminate enrollment in this study is based on the company's change in prioritization for the portfolio and was not due to any safety concerns, or regulatory interactions.
Patients already enrolled in the study, should continue to complete assessments as described in the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male subjects and surgically sterile or postmenopausal female subjects between the ages of 25 and 75 years old with specific full-thickness RCTs identified on closed MRI within 3 months before surgery.
排除标准
- •Subjects who have had previous surgical intervention to the shoulder joint under study or additional injury requiring surgical repair or a history of shoulder dislocation in the affected shoulder or physical examination findings of instability in either shoulder
- •Subjects who are unable to complete functional evaluations because of any other concurrent injuries or impairment in either the arm
- •Subjects identified with specific fatty infiltration of their RC muscles on MRI taken within 3 months prior to surgical repair
- •Subjects with moderate or severe degenerative arthritis of the shoulder under study or any bone abnormalities as confirmed on a radiograph
- •Subjects with rheumatologic conditions affecting the shoulder joints or autoimmune disorders, treated with more than 3 corticosteroid injections in the shoulder under study within 1 year of planned surgery, any recent corticosteroid injection in the shoulder or currently receiving oral corticosteroids
- •Subjects who are either unwilling or unable to undergo examination with closed MRI.
研究组 & 干预措施
1
Experimental
Arm A
干预措施: BMP-655/ACS or Standard of Care (Biological)
2
Experimental
Arm B
干预措施: BMP-655/ACS or Standard of Care (Biological)
3
Experimental
Arm C
干预措施: BMP-655/ACS or Standard of Care (Biological)
结局指标
主要结局
Abnormal X-rays, MRIs, CT scans, physical examination of limb, functional evaluations, AE/SAE, vital signs, subject assessment of pain, lab tests
时间窗: 1 year
次要结局
- Investigator Questionnaire(1 year)
研究者
研究点 (4)
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