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:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT01675167
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of moderate to severe low back pain for ≥6 months
* Treating CLBP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥30 mg and ≤160 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed \[PRN\] analgesic rescue medications permitted on top of the stable daily maintenance dose of ≥30 mg MSE opioid analgesic, but must be included in the total daily MSE calculation and in combination with the stable daily maintenance dose not to exceed 160 mg MSE per day)
* Stable health, as determine by Principal Investigator
* Females are practicing abstinence, using a medically acceptable form of contraception, or post-menopausal, biologically sterile, or surgically sterile for more than 1 year
* Willing and able to comply with all protocol required visits and assessments
Exclusion Criteria:
* Current cancer related pain or received chemotherapy within 6 months of screening
* Subjects with history of other chronic painful conditions
* Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
* Allergy or contraindications of any opioid or acetaminophen
* Surgical procedure for relief of pain within 6 months
* Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
* QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the 12-lead electrocardiogram (ECG)
* History of long QT syndrome or a family member with this condition
* Moderate to severe hepatic impairment
* Moderate to severe renal impairment
* Current or past history of alcohol abuse
* Positive urine toxicology screen for drug of abuse
* History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01675167
Study Brief:
Protocol Section:
NCT01675167