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-PL

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

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

Exclusion Criteria

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.