EUCTR2004-002344-99-GB进行中（未招募）1 期
A Phase 2, Multicenter, Randomized, Double-Blind, Dose-Escalating/De-Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sustained-Release Encapsulated Bupivacaine (SKY0402) Administered as a Nerve Block in the Management of Post-Operative Pain in Subjects Undergoing Bunionectomy - N/A
SkyePharma, Inc.0 个研究点目标入组 88 人开始时间: 2005年3月3日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Males and females* greater than or equal to 18 years of age. *Note: Eligible females must be post-menopausal or surgically sterile, or, if of childbearing potential, they must not be pregnant or nursing, and they must agree not to become pregnant during the study by using acceptable means of contraception for at least one month before and one month after dosing, including any of the following: hormonal contraceptives (oral, injectable, implantable), effective barrier methods (e.g. condoms with spermicide), intrauterine device (IUD), lifestyle with a personal choice of abstinence, non-hetrosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy.
- •2. Scheduled to undergo a primary unilateral first metatarsal bunionectomy repair** under general anesthesia with or without internal fixation. ** Note: For the purpose of this protocol, all surgical procedures involving osteotomy of the first metatarsal (significant bone resection, excision, surgical fracture, etc.) or fusion of the first metatarsal-phalangeal joints are considered qualified procedures, whether or not performed specifically to repair a bunion (hallus valgus deformity). Surgical techniques accompanied by minimal bone excision (e.g. Cheilectomy) or procedures limited to soft tissue repair are NOT eligible for this study.
- •3. ASA Physical Class 1 or 2
- •4. Able and willing to comply with all study visits and procedures
- •5. Capable of speaking and understanding the local language sufficiently to provide responses to pain assessment scales
- •6. Willing and capable of providing written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Clinically significant ECG abnormalities at Screening or on Day 1 (pre-dose)
- •2. Albumin and/or alpha 1-acid glycoprotein below normal levels
- •3. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, might increase the risk of surgery or complicate the subject's post-operative course
- •4. Opioid medication usage during the 7-day period preceeding the administration of the study drug
- •5. Current medical conditions that could require treatment with analgesic medications in the post-operative period for pain that is not surgically related (e.g. rheumatoid arthritis)
- •6. Body mass index greater than 30
- •7. Body weight less than 60 kilograms
- •8. History of hypersensitivity or idiosyncratic reaction to amide-type local anaesthetic agents
- •9. History of hypersensitivity or idiosyncratic reactions to the pain control agents (opioid or non opioid) anticipated to be used post-operatively. These contraindications may include: angioedema and bronchospastic reactivity to NSAID, peptic ulcer (active within the last three months), hepatic or renal insufficiency.
- •10. Coagulation disorders or ongoing anticoagulation treatment
- •11 Administration of an investigational drug within 30 days or 5 half lives prior to the study
- •12. Suspected or known history of substance abuse and/or alcoholism
研究者
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