CompletedPhase 4

Training "Pain Connoisseurs" for Efficient Analgesic Proof-of-Concept Studies

United States98 participantsStarted 2013-08

Plain-language summary

The purpose of this study is to assess the ability of Evoked Pain Training (EPT) and Drug/ Placebo Administration (DPA) training to increase subjects' ability to discriminate between active and placebo treatments in a double-blind crossover trial of a known analgesic, measured by standardized effect size, relative to untrained control subjects.

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

. Be a man or a non-pregnant, non-lactating woman 18 years or older. Women of childbearing potential should be willing to use an acceptable birth control method (at the Investigator's discretion) during the study to avoid pregnancy.
. Have voluntarily provided written informed consent.
. Be able to speak, read, write, and understand English, understand the consent form, complete study-related procedures, and communicate with the study staff.
. Have a clinical diagnosis of Painful Diabetic Neuropathy (PDN) for at least 6 months.
. Have a pain intensity score averaging ≥4 on a 0-10 NRS for average daily recall over past 24 hours. (This applies at V1, V2, and V5.)
. Have an average daily pain intensity of at least 4 on the 0-10 NRS on at least 20 out of the past 30 days.

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

Pain Assessment Training

Timeframe: 1 year

Trial details

NCT IDNCT02842554

SponsorAnalgesic Solutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10

View on ClinicalTrials.gov More Painful Diabetic Neuropathy (PDN) trials

Plain-language summary

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

. Be a man or a non-pregnant, non-lactating woman 18 years or older. Women of childbearing potential should be willing to use an acceptable birth control method (at the Investigator's discretion) during the study to avoid pregnancy.
. Have voluntarily provided written informed consent.
. Be able to speak, read, write, and understand English, understand the consent form, complete study-related procedures, and communicate with the study staff.
. Have a clinical diagnosis of Painful Diabetic Neuropathy (PDN) for at least 6 months.
. Have a pain intensity score averaging ≥4 on a 0-10 NRS for average daily recall over past 24 hours. (This applies at V1, V2, and V5.)
. Have an average daily pain intensity of at least 4 on the 0-10 NRS on at least 20 out of the past 30 days.

Training "Pain Connoisseurs" for Efficient Analgesic Proof-of-Concept Studies

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Training "Pain Connoisseurs" for Efficient Analgesic Proof-of-Concept Studies

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria