A Study Comparing the Safety and Analgesic Efficacy of ABT-110 inSubjects with Pain from Osteoarthritis of the Knee

• Conditions: Pain from Osteoarthritis of the Knee; MedDRA version: 15.1Level: LLTClassification code 10031165Term: Osteoarthritis kneeSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-002144-27-FI
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-25
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified