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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT00058968
Eligibility Criteria:
Inclusion Criteria:
* Male or female outpatients at least 18 years of age.
* Patients with pain due to diabetic neuropathy in both legs.
* Females must not be pregnant or plan to become pregnant during the study.
* Stable Glycemic control.
* Average mean pain severity score of at least 4.0 as assessed by completion of a daily diary.
Exclusion Criteria:
* You are related to or work for the physician conducting the study or are employed by Eli Lilly and Company.
* You have a severe or serious medical condition that causes you to be hospitalized often; or you have had a kidney transplant or are on current dialysis.
* You have participated in a study for an investigational drug within the last 30 days.
* You have a history of major depressive disorder, generalized anxiety disorder, or alcohol or eating disorders.
* You have a past medical history or diagnosis of mania, bipolar disorder, or psychosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00058968
Study Brief:
Protocol Section:
NCT00058968