Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 72
研究概览
简要总结
OBJECTIVES: I. Compare the safety and efficacy of clostridial collagenase vs placebo in terms of improving the degree of flexion deformity, range of finger motion, and grip strength in patients with residual stage Dupuytren's disease.
II. Compare the overall clinical success rate, time to return to normal finger contracture to within 0-5 degrees of normal (zero degrees), and frequency of cord rupture in the joint of patients treated with these regimens.
III. Compare the baseline change in degree of finger flexion deformity, range of motion of the treated finger, and strength of hand grip (in pounds) in patients treated with these regimens.
IV. Compare the frequency distribution of the number of patients with reduction in finger contracture to within 0-5 degrees of normal (zero degrees) and the number who require re-treatment with open-label collagenase after treatment with these regimens.
详细描述
PROTOCOL OUTLINE: This is a randomized, investigator-blinded, placebo-controlled, multicenter study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive a single collagenase injection into the target finger cord on day 0.
Arm II: Patients receive a single placebo injection as in arm I.
Both arms: After the 1 month evaluation, patients who are unresponsive to treatment may receive monthly injections of collagenase for a maximum of 5 injections.
Beginning at 1 day after completion of treatment, patients use a joint nighttime extension splint for 4 months and perform finger flexion/extension exercises.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Diagnosis of residual stage Dupuytren's disease with fixed flexion deformity of the finger(s) of at least 20-30 degrees caused by a palpable cord
- •Positive table-top test (inability to simultaneously place affected finger and palm flat against a table top)
- •-Prior/Concurrent Therapy--
- •At least 30 days since prior surgery for Dupuytren's disease At least 30 days since prior participation in a trial with an investigational drug
- •-Patient Characteristics--
- •Hematopoietic: No history of hematologic disease
- •Hepatic: No history of hepatic disease
- •Renal: No history of renal disease
- •Cardiovascular: No congestive heart failure, angina, or myocardial infarction within the past 6 months
- •Pulmonary: No history of respiratory disease
- •Not immunocompromised
- •HIV negative
- •No history of significant illness (e.g., endocrine or neurologic disease)
- •No psychosis
- •No history of illicit drug abuse or alcoholism within the past year
- •No infectious illness within the past 2 weeks
- •No chronic or debilitating disease
- •No IgE antibodies to collagenase exceeding 15 ng/mL
- •No known allergy to collagenase or any of the inactive ingredients in the drug
- •No other condition or circumstance that would preclude study
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
排除标准
- 未提供