CompletedPhase 3

A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients

Belgium, Czechia, France468 participantsStarted 2011-11

Plain-language summary

The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.

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: * Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes * Stable glycemic control for at least 6 months prior to screening visit * Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of \>4 at the screening and the baseline visit Exclusion Criteria: * Primary pain associated with PDPN in the ankles or above * Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN * Significant pain (moderate or above) of an etiology other than PDPN, that may interfere with judging PDPN-related pain * Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study. * Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter \[OTC\] capsaicin products), any QUTENZA excipients, Eutectic Mixture of Local Anesthetics( EMLA) ingredients or adhesives

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

Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale

Timeframe: Baseline till endpoint (discontinuation or End of Study visit) (up to 64 weeks)

Trial details

NCT IDNCT01478607

SponsorAstellas Pharma Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02

View on ClinicalTrials.gov More Painful Diabetic Peripheral Neuropathy (PDPN) 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.