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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT00073034
Eligibility Criteria:
Inclusion Criteria:
* Women of childbearing potential must have a negative serum pregnancy test result at screening
* Diabetes mellitus (type I or II) that is controlled by oral or parenteral hypoglycemic agents or diet
* Diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy
Exclusion Criteria:
* Pregnancy, lactation, or plans to become pregnant during the study
* Depo-Provera or oral contraceptives that have been taken for less than 1 month before study day 1 if not using another medically accepted form of birth control
* History of multiple drug allergies that may put the subject at greater risk during study participation in the opinion of the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00073034
Study Brief:
Protocol Section:
NCT00073034