Training "Pain Connoisseurs" for Efficient Analgesic Proof-of-Concept Studies (NCT02842554) | Clinical Trial Compass
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 range18 Years
SexALL
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.
✓. Be, in the opinion of the Investigator, in sufficiently good health to participate in the study at screening, based upon the results of a medical history, physical examination and laboratory analysis.
Exclusion criteria
✕. Are pregnant and/or lactating.
✕. Have been diagnosed as having any inflammatory arthritis, gout, pseudo-gout, Paget's disease, fibromyalgia or any chronic pain syndrome that in the Investigator's opinion would interfere with the assessment or self-evaluation of pain and other symptoms of PDN.
✕. Have evidence for multiple causes of pain in the neuropathic pain area, such as lumbar radiculopathy.
✕. Have received or used any of the excluded/prohibited treatments or drugs specified in the list of prohibited treatments (below) or are unable to agree to the list of treatments prohibited during the study.
✕. Have a history of congestive heart failure, unstable coronary artery disease, stroke, or uncontrolled hypertension.
✕. Have a history of significant gastrointestinal disease, including active gastro-duodenal ulcerations, perforations, or bleeds.
✕. Have abnormal clinical laboratory test results or vital signs unless deemed not clinically significant by the investigator.
✕. Have regularly worn false fingernails within the past 6 months (more than 25% of the time)