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 350 人开始时间: 2011年12月20日最近更新: 2013年3月4日

试验速览

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•1. Subject is between 18 and 70 years of age, inclusive.
•2. Osteoarthritis pain in the index knee which meets the following:
•? History of pain in the index knee = 6 months; AND
•? K-L Grade 2 or 3 only on plain radiographs of the index knee; 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. Subject 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 the Screening Visit.
•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. Subject is scheduled for or is considering joint replacement surgery at any time during the study.
•2. Subject has had any of the following:
•? Joint replacement/reconstruction to either knee;
•? Any major surgery to the index knee within 12 months
•prior to the Screening Visit; OR
•? Arthroscopic surgery to the index joint within 3 months prior to the Screening or trauma to the index knee within 12 months prior to Screening.
•3. Subject has a history of osteonecrosis or rapidly progressive osteoarthritis in any joint.
•4. Subject has OA of the index knee that meets the K-L classification criteria of grade 0, 1 or 4 and OA of the contralateral knee that meets the K-L classification criteria of grade 4.
•5. Subject has radiographic evidence of OA of the hip or shoulder joints.

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