A Phase 2, Multicenter, Randomized, Double-Blind, Dose-Escalating/De-Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of a Single Dose of Sustained-Release Encapsulated Bupivacaine (SKY0402) in the Management of Post-Operative Pain in Subjects Undergoing Inguinal Hernia Repair - N/A

SkyePharma, Inc.0 个研究点目标入组 88 人开始时间: 2005年2月23日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•1. Males greater than or equal to 18 years of age
•2. Scheduled to undergo a unilateral inguinal hernia repair under general anesthesia, using an open, tension free procedure (e.g. Lichenstein technique with or without mesh
•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

•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 kg
•8. History of hypersensitivity or idiosyncratic reaction to amide-type local anaesthetic agents
•9. History of hypersensitivity reaction 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 3 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

发起方

SkyePharma, Inc.