Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT01256450
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant and non-nursing female aged 18 or older
* History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 \[11 point numerical rating scale\] reported at the open-label titration period Day 0/1 visit following a washout period (opioids, nonsteroidal anti-inflammatory drugs \[NSAIDs\], and muscle relaxants) of approximately 12 to 24 hours
* Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer
* Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and screening laboratory results so as to comply with all study procedures
* Female subjects of childbearing potential must be using a recognized effective method of birth control
* Written informed consent obtained at Screening, prior to any procedure being performed
Exclusion Criteria:
* Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis
* Surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening
* Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
* Corrected QT (QTc) interval of \>450 milliseconds on the 12-lead electrocardiogram (ECG)
* History of long QT syndrome, or an immediate family member with this condition
* Diagnosis of moderate to severe hepatic impairment.
* History of severe emesis with opioids
* Clinically significant sleep apnea
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01256450
Study Brief:
Protocol Section:
NCT01256450