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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT00625833
Eligibility Criteria:
Inclusion Criteria:
* Male or female of any race at least 18 years of age
* Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year
* Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale
Exclusion Criteria:
* Patients with significant hepatic impairment
* Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain
* Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy
* Amputations other than toes
* A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression
* History of transient ischemic attack or stroke
* Myocardial infarction or unstable angina within the past three months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00625833
Study Brief:
Protocol Section:
NCT00625833