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Training "Pain Connoisseurs" for Efficient Analgesic Proof-of-Concept Studies | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT02842554•Analgesic Solutions

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A subject must meet all of the following criteria to be enrolled in the study:
•1. 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.
•2. Have voluntarily provided written informed consent.
•3. Be able to speak, read, write, and understand English, understand the consent form, complete study-related procedures, and communicate with the study staff.
•4. Have a clinical diagnosis of Painful Diabetic Neuropathy (PDN) for at least 6 months.
•a. Clinical diagnosis may be verified by medical records or by clinical examination during the first visit combined with a medical history of appropriate symptoms for at least 6 months.
•5. 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.)
•6. 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.
•7. 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.
•Prior to each Treatment Period, the participants must meet the following additional criteria for randomization: Have average pain intensity (24-hour recall) ≥4 on the 0-10 NRS.

Exclusion Criteria

•A subject must be excluded if any of the following criteria are met:
•1. Are pregnant and/or lactating.
•2. 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.
•3. Have evidence for multiple causes of pain in the neuropathic pain area, such as lumbar radiculopathy.
•4. 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.
•5. Have a history of congestive heart failure, unstable coronary artery disease, stroke, or uncontrolled hypertension.
•6. Have a history of significant gastrointestinal disease, including active gastro-duodenal ulcerations, perforations, or bleeds.
•7. Have abnormal clinical laboratory test results or vital signs unless deemed not clinically significant by the investigator.
•8. Have regularly worn false fingernails within the past 6 months (more than 25% of the time)
•9. Are undergoing active treatment for cancer, are known to be infected by human immunodeficiency virus, or are being acutely and intensively immunosuppressed following transplantation.
+9 more criteria

Locations (1)

Analgesic Solutions

Natick, Massachusetts, United States

Key Dates

Start Date

August 1, 2013

Primary Completion Date

October 1, 2015

Completion Date

October 1, 2015

Last Updated

July 25, 2016

Enrollment

ACTUAL participants

Conditions

Painful Diabetic Neuropathy (PDN)

Interventions

EPT

OTHER

Drug Placebo Administration

DRUG

OTHER