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 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT04106050
Eligibility Criteria:
Key Inclusion Criteria:
* Healthy participants must be in good health, as determined based on medical history and screening evaluations
* Participants with DPN
* Must have a documented diagnosis of type 2 diabetes mellitus (DM)
* Must have stable glycemic control
* Must have at least clinical evidence of painful DPN
* Pain related to DPN must be present for at least 6 months prior to screening
* Average daily pain intensity over 7 consecutive days recorded during screening must be ≥ 4 on an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Key Exclusion Criteria:
* Any neurologic or painful condition that could confound the interpretation of study results
* History of any clinically significant cardiac, hematologic, hepatic, immunologic, urologic, pulmonary, dermatologic, psychiatric, renal, or other major disease. This includes any clinically significant endocrinologic or neurologic disease other than DM or DPN.
* Use of local anesthetics or capsaicin for topical or regional treatment within 3 months prior to Screening.
* Systemic use of sodium channel inhibitors
Note: Other protocol-specific inclusion/exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04106050
Study Brief:
Protocol Section:
NCT04106050