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

Abbott GmbH & Co. KG0 个研究点目标入组 390 人开始时间: 2011年10月19日最近更新: 2013年1月21日

适应症

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 must meet the following pain criteria at the time of the Baseline Visit:
•? Subject's Assessment of Arthritis Pain Intensity (VAS) of the index knee is = 40 mm with an increase of = 10 mm from the Screening Visit,
•o For subjects whose Screening VAS is = 85 mm, a VAS of = 85 mm must be maintained at the Baseline Visit; AND
•? Subject's Global Assessment of Arthritis Status must be Fair, Poor or Very Poor.
•4. Subject requires therapeutic doses of at least 1 non-opioid analgesic for OA pain 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 310
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•1. Subject is scheduled for or is considering joint replacement surgery within 6 months following the Screening Visit.
•2. Subject has had any of the following:
•? Joint replacement/reconstruction to the index joint at any time;
•? Any major surgery, e.g., open surgery, to the index joint within 12 months
•prior to the Screening Visit; OR
•? Arthroscopic surgery to the index joint within 3 months prior to the Screening
•3. Subject has a history of osteonecrosis in any joint.
•4. Subject has OA of the knee that meets the K-L classification criteria of grade 0, 1

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