A Study Comparing the Safety and Analgesic Efficacy of ABT-110 in Subjects with Chronic Low Back Pai

• Conditions: Chronic Low Back Pain; MedDRA version: 15.1Level: LLTClassification code 10008837Term: Chronic back painSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-002143-95-PL
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-20
• Last Update Posted: 4 March 2013

Recruitment & Eligibility

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

Inclusion Criteria

1) Between 18 and 70 years of age,
2) History of CLBP below the 12th thoracic vertebrae and above the crease of the buttocks, = 6 months duration,
3) Subject requires therapeutic doses of at least 1 oral analgesic for CLBP 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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1) Has CLBP with any of the following a) pain with distal extremity radiation b) pain with radiation and neurologic findings c) spinal nerve root compression,
2) Has any of the following spinal cord conditions a) tumor, b) infection of the spinal cord or surrounding structures within the past 5 years, c) spinal stenosis with neurogenic claudication, d) spondylolisthesis with distal radiation and/or neurologic findings, e) seronegative spondylarthropathy
3) Has osteoarthritis of the large joints as evidenced by a) history or prior diagnosis of OA in the knee, hip or shoulder, b) clinical findings consistent with ACR Clinical and Radiographic Criteria for OA of the knee, hip or shoulder, or radiographic findings of OA in the knee, hip or shoulder (Kellgren-Lawrence = 2),
4) History of osteonecrosis or rapidly progressive
osteoarthritis in any joint.

Study & Design

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