ACTRN12610001045000已完成3 期
An open-label study to assess the safety, tolerability and multiple-dose phamacokinetics of AA4500 0.58 mg in subjects with dupuytren's contractures.
Auxilium Phamaceuticals, Inc.0 个研究点目标入组 12 人开始时间: 2010年11月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Provide written informed consent
- •2. Be a man or woman greater than of equal to18 years of age and less than or equal to 70 years
- •3. Have a diagnosis of Dupuytren’s disease and have at least 3 fixed-flexion contractures (2 must be on the same hand) that are = 20 degrees in PIP and/or MP joints in fingers, other than the thumbs, which are caused by palpable cords suitable for treatment
- •4. Have a positive table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top
- •5. Be naive to AA4500 treatment
- •6. Either be using an accepted method of birth control (ie, surgical sterilization; intra uterine contraceptive device; oral contraceptive; diaphragm or condom in combination with contraceptive cream, or jelly or foam) and have negative pregnancy testing before administration of AA4500, if a female of childbearing potential or be a postmenopausal female (no menses for at least 1 year or hysterectomy)
- •7. Not have any clinically significant medical history or condition(s) that would, in the opinion of the investigator, substantially increase the risk associated with the subject’s participation in the protocol or compromise the scientific objectives of the study
- •8. Be able to comply with the study visit schedule as specified in the protocol
排除标准
- •1. Received surgery (fasciectomy or surgical fasciotomy) and/or needle aponeurotomy/fasciotomy on the selected joints to be treated within 90 days before the first injection of AA4500
- •2. Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
- •3. Has a known systemic allergy to collagenase or any other excipient of AA4500
- •4. Has received any other collagenase treatments (eg, Santyl (Registered Trademark) ointment) within 30 days before injection of AA4500
- •5. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for = 150 mg aspirin daily and over-the-counter nonsteroidal anti-inflammatory drugs [NSAIDs]) within 7 days before injection of AA4500
- •6. Has a known recent history of stroke, bleeding, or other medical condition, which in the investigator’s opinion would make the subject unsuitable for enrollment in the study
- •7. Has significant renal or hepatic impairment, which in the opinion of the investigator, could compromise the scientific objectives of the study
- •8. Is known to be immunocompromised or human immunodeficiency virus (HIV) positive
- •9. Has a history of illicit drug abuse or alcoholism within the year before injection of AA4500
- •10. Has a positive alcohol breath test or a positive urine drug screen within 3 days before admission to the study unit
- •11. Received an investigational drug within 30 days before injection of AA4500
- •12. Is a pregnant or lactating female
- •13. Has any clinically significant medical history or condition(s), including conditions that affect the hands, that would, in the opinion of the investigator, substantially increase the risk associated with the subject’s participation in the protocol or compromise the scientific objectives of the study
- •14. Has jewelry on the hand to be treated that cannot be removed
- •15. Requires a local anesthetic before injection of AA4500 or before the finger extension procedure in multiple-dose Period 2
研究者
相似试验
进行中（未招募）
1 期
The VIOLIN Study: to Evaluate etravirine Tolerability, Pharmacokinetics With Other Antiretrovirals In Treatment Experienced PatientsEUCTR2010-023532-16-ROJanssen R&D Ireland211
进行中（未招募）
1 期
Study to evaluate the safety, tolerability, and efficacy of LOmitapide for the treatment of patients with Familial CHylomicroNEmia SyndromeFamilial Chylomicronemia SyndromeMedDRA version: 20.0Level: PTClassification code 10058108Term: DyslipidaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2018-002911-80-ITPRM|2121820
已完成
1 期
A study to evaluate the safety, tolerability, and pharmacokinetics of a medicinal cannabinoid oil formulation in chronic non-cancer pain participants on long term opioid treatmentschronic painAnaesthesiology - Pain managementACTRN12619001013156Zelda Therapeutics9
招募中
不适用
To investigate safety, tolerability and acceptability of needle free injection system in healthy volunteers in comparison to conventional needle-based system.CTRI/2021/01/030587IntegriMedical
招募中
1 期
Phase I study of a Latanoprost Ocular Implant for treatment of Open Angle Glaucoma or Ocular Hypertension.Ocular HypertensionACTRN12621001718831PolyActiva Pty Ltd6