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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00375960
Eligibility Criteria:
Inclusion Criteria:
* Males or females 18-75 years of age
* Diabetes mellitus (type I or type II)
* No change in medications for reducing blood sugar within 4 weeks before screening
* Experiencing daily pain due to diabetic neuropathy for at least 6 months but not more than 5 years
* Neuropathic pain must begin in the feet, with relatively symmetrical onset.
* Willing to perform self-monitoring of blood glucose
* Able to communicate intelligibly with the investigator and study coordinator
* Keeping all appointments for clinic visits, tests, and procedures
Exclusion Criteria:
* Any clinically significant neurologic disorders (with the exception of diabetic peripheral neuropathic pain)
* Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study
* Prior renal transplant or current renal dialysis
* Pernicious anemia
* Untreated hypothyroidism
* Amputations due to diabetes mellitus (with the exception of toes)
* Any clinically significant abnormal electrocardiogram (ECG)
* Any history of cardiac arrhythmia
* History of myocardial infarction
* Active angina
* Uncontrolled hypertension (i.e., \> 140/90 mm Hg)
* Known or at high risk of hepatitis B or C infection
* Known or at high risk of human immunodeficiency virus (HIV) infection
* Any anticipated need for surgery during the study
* Glycosylated hemoglobin (HbA1c) \> 9%
* Known seizure disorder
* Any malignancy in the past 2 years (with the exception of basal cell carcinoma)
* Pain that cannot be clearly differentiated from, or conditions that interfere with the assessment of diabetic neuropathic pain.
* Use of anticonvulsants, antidepressants, or prescription membrane-stabilizing agents
* History of substance abuse or dependence within the past year, excluding nicotine and caffeine
* Frequent and/or severe allergic reactions with multiple medications
* Participation in any clinical trial within 30 days before screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00375960
Study Brief:
Protocol Section:
NCT00375960