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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT02100956
Eligibility Criteria:
Inclusion Criteria:
* Weight \< or equal to 240 pounds
* Neuropathic pain for \> 6 months: with primary pain area below the umbilicus
Exclusion Criteria:
* Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug or lidocaine
* Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
* Pregnancy
* spinal cord stimulators, chronic intrathecal drug therapy, or oral opioid treatment for \> 3 months at a current dose of \> 100 milligram (mg) morphine per day or equivalent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02100956
Study Brief:
Protocol Section:
NCT02100956