A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy. (NCT00625833) | Clinical Trial Compass
TerminatedPhase 2
A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
Stopped: Study was terminated for futility following the planned interim analysis.
United States, Czechia, Finland330 participantsStarted 2007-12
Plain-language summary
This is a trial to investigate the effectiveness and safety of \[S,S\]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of \[S,S\]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.
Who can participate
Age range
18 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:
* 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
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.