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 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT03372161
Eligibility Criteria:
Main Inclusion Criteria:
* Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures.
* Age 18 to 70 years (inclusive) at the Screening Visit.
* A diagnosis of lumbosacral radicular pain (sciatica).
* Agrees to follow study-specific medication requirements.
* If sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study.
* Has reviewed all study specific materials and has, in the opinion of the Investigator, the abilities to understand and appropriately complete all study procedures.
Main Exclusion Criteria:
* Has radiologic evidence of a condition that would compromise study outcomes.
* Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study.
* Has been diagnosed with insulin dependent diabetes mellitus.
* Presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the Investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
* Use of any investigational drug and/or device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study.
* Has a body mass index ≥40 kg/m2.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03372161
Study Brief:
Protocol Section:
NCT03372161