A Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Study Comparing the Safety and Analgesic Efficacy of ABT-110 to Placebo in Subjects with Pain from Osteoarthritis of the Knee

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 330 人开始时间: 2012年7月25日最近更新: 2013年1月7日

适应症

试验速览

暂无简介。

•1) Between 18 and 70 years of age
•2) Osteoarthritis in the index knee which meets the following: History of pain the index knee = 6 months and Kellgren & Lawrence Grade 2 or 3 only on plain radiographs AND at least 1 of the following 3 criteria: Age > 50 years or stiffness < 30 minutes upon awakening or crepitus in the index knee
•3) Requires therapeutic doses of at least 1 oral analgesic for OA pain (NSAIDS, COX-2 inhibitors, Tramadol or tapentadol, opioids) during the previous 3 months with a stable dose for at least 4 days per week during the 4 weeks prior to Screening
•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 290
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•1) Scheduled for or is considering joint replacement surgery at any time during the study
•2) Has had joint repleacement /reconstruction to either knee, any major surgery to the index knee within the 12 months prior to screening, or arthroscopic surgery to the index knee within 3 months prior to screening or trauma to the index knee within 12 months prior to Screening
•3) Has a history of osteonecrosis or rapidly progressive osteoarthritis in any joint
•4) Has OA of the index knee that meets K-L classification grade 0, 1, or 4 and OA of the contralateral knee that meets the K-L classification criteria of grade 4
•5) Has radiographic evidence of OA of the hip or shoulder joints

发起方