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-FI
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-26
• 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) History of CLBP below the 12th thoracic vertebrae and above the crease of the buttocks, = 6 months duration
3) Requires thereapeutic doses of at least 1 oral analgesic for CLBP (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 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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective for this study is to compare the safety, tolerability and the analgesic efficacy of ABT-110 administered subcutaneously (SC) once every 8 weeks (q8w) for a total of two doses to placebo in subjects with CLBP.;Secondary Objective: The secondary objective of this study is to explore population pharmacokinetics of ABT 110 in subjects with CLBP.;Primary end point(s): Change from baseline to Week 16 in pain intensity as measured by a 100 mm Visual Analog Scale (VAS);Timepoint(s) of evaluation of this end point: 16 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Roland-Morris Disability Questionnaire, EQ-5D-5L, WPAI;Timepoint(s) of evaluation of this end point: 8 and 16 weeks