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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT01669967
Eligibility Criteria:
Inclusion Criteria:
* Chronic neuropathic pain due to diabetes mellitus or herpes zoster and a score of 4/10 or greater on the DN4 questionnaire.
* Moderate to severe pain as defined by screening average pain intensity of 5 or greater on a 0-10 numerical rating scale.
* Neuropathic pain duration of at least 6 months.
Exclusion Criteria:
* Presence of clinically significant cardiac disease.
* Poorly controlled seizure disorder.
* Significant psychiatric disorder.
* History of allergy to lidocaine or any other amide local anesthetic
* History of allergy to diphenhydramine.
* Prior treatment with a local anesthetic infusion.
* Neuropathic pain due to cancer or complex regional pain syndrome
* Language barrier or cognitive impairment that would preclude understanding of the study and filling out of questionnaires
* Lack of a driver to transport the patient to and from the pain clinic.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01669967
Study Brief:
Protocol Section:
NCT01669967