Double-blind, Randomized Placebo Controlled Study of the Relative Safety and Efficacy of Collagenase Therapy in the Treatment of Residual-type Dupuytren's Disease.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.
研究概览
简要总结
The purpose of the study is to determine if collagenase will reduce the degree of contracture in the primary joint in subjects with Dupuytren's disease.
This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
详细描述
In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to disrupt the Dupuytren's cord.
Resultant cord disruption may obviate the need for patients to have surgery to correct the finger flexion contractures of Dupuytren's disease.
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
- Double (Participant, Investigator)
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
- •Subjects were at least 18 years of age, of either sex or any race.
- •Subjects had residual Dupuytren's disease with a fixed-flexion deformity of the finger(s) of at least 20 degrees or greater, caused by a palpable cord.
- •Subjects had a positive "table-top test" defined as the inability to simultaneously place their affected finger(s) and palm flat against a table top.
- •Subjects must have been willing to participate in and complete the study, and comply with its procedures by signing an IRB approved written consent form.
- •Subjects must have been able to understand and adhere to the visit schedule. They must have been able to follow study procedures and instructions, and have agreed to report concomitant medications and adverse events accurately and consistently.
- •Women of childbearing potential must have agreed to use an acceptable method of birth control or must have been surgically sterilized (hysterectomy or tubal ligation). Women of childbearing age had a urine pregnancy test on Day 0 (day of injection) prior to the injection.
- •Exclusion Criteria
- •Women who were nursing or who were pregnant (as evidenced by a positive urine pregnancy test at the time of enrollment).
- •Subjects who had participated in an investigational drug trial within 30 days of enrollment in this study.
- •Subjects who had received surgery for Dupuytren's disease within 30 days of enrollment in this study.
- •Subjects who had a known allergy to AA4500 or any of the inactive ingredients in the AA4500 injection.
- •Subjects who had a known allergy to doxycycline.
- •Subjects who had a medical condition that would have made them unsuitable for enrollment.
排除标准
- 未提供
结局指标
主要结局
Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.
时间窗: 30 days after the last injection
The Primary Outcome Measure for patients treated with AA4500 is the percentage of 23 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less. The Primary Outcome Measure for placebo treated patients is the percentage of 12 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.
次要结局
- Percent Reduction From Baseline Contracture After the Last Injection(30 days after last treatment to the primary joint)
- Percent Change From Baseline Range of Motion After the Last Injection(30 days after last treatment to the primary joint)
- Time to First Achieve and Maintain Clinical Success After the Last Injection(First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint)
- Clinical Success After the First Injection(30 days after first treatment to the primary joint)
- Percent Reduction From Baseline Contracture After the First Injection(30 days after first treatment to the primary joint)
- Change From Baseline Range of Motion After the First Injection(30 days after first treatment to the primary joint)