chronic low back pain
Conditions
Interventions
The study will start with a screening. At the screening a physical-, and
neurological examination will take place and a few other standard medical
assessments will be performed ( Vital Signs, ECG).
Sponsors
Abbott
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy Volunteers: Male or female aged 18-55 years; females must be postmenopausal or surgically sterilized; BMI between 18 and 29 inclusive; general good health. CLBP Subjects: Male or female aged 18-60 years; females must be postmenopausal or surgically sterilized; chronic pain located below 12th rib and above lower gluteal fold of at least 6 months duration and meeting protocol-specified pain severity criteria; must be currently taking an NSAID, atypical analgesic (e.g. tramadol or tapentadol), or opioid analgesic for CLBP with inadequate analgesia.
Exclusion criteria
Exclusion criteria: Healthy Volunteers: Any clinically significant medical problems. CLBP Subjects: Any radiation of pain below the lower gluteal fold; any back injury within 3 months prior to study drug; history of back surgery within 1 year prior to study drug; radiographic evidence (x-ray) of osteoarthritis (OA) in any shoulder, hip or knee joint; history of osteonecrosis (avascular necrosis) or rapidly progressive OA in any joint; use of corticosteroids within the past year that meets protocol-specified criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics, safety and tolerability in healthy volunteers | — |
Secondary
| Measure | Time frame |
|---|---|
| - Relative bioavailability of subcutaneously versus intravenously administration of the study drug - Pharmacokinetics, safety and tolerability in subjects with CLBP | — |
Countries
Netherlands
Outcome results
None listed