A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain (NCT00375960) | Clinical Trial Compass
CompletedPhase 2
A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain
United States, Canada50 participantsStarted 2006-06
Plain-language summary
The objective of this study is to investigate the safety and efficacy of an investigational drug, V3381, for the treatment of diabetic peripheral neuropathic (DPN) pain (pain in one's feet and legs, or even in one's hands and arms, sometimes experienced by people with diabetes). An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) and/or Health Canada.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
11 point numerical pain rating scale (NPRS) daily diary