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

NCT02842554 | Completed Phase 4

• 1 other identifier: GRN.PC.002
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Painful Diabetic Neuropathy (PDN)

Keywords

PDN; Painful Diabetic Neuropathy; Diabetes

Outcome Measures

Primary Outcomes (1)

• Pain Assessment Training

  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

  1 year

Secondary Outcomes (1)

• Predicted Response to Training

  1 year

Study Arms (3)

DPA

OTHER

Drug Placebo Administration

Drug: Drug Placebo Administration

C

OTHER

Control

Other: C

EPT

OTHER

Evoked Pain Training

Other: EPT

Interventions

EPT OTHER

EPT

Drug Placebo Administration DRUG

DPA

C OTHER

No Intervention

Also known as: Control

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A subject must meet all of the following criteria to be enrolled in the study:
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• A subject must be excluded if any of the following criteria are met:
• 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)
• Are undergoing active treatment for cancer, are known to be infected by human immunodeficiency virus, or are being acutely and intensively immunosuppressed following transplantation.
• Have a history of alcohol or other substance abuse (not including nicotine or tobacco) within 5 years.
• Have a history of suicide attempt within the past 1 year or suicidal ideation within the past 1 month.
• Have a history of epilepsy or other seizure disorder.
• Have creatinine clearance below 60 mL/min as calculated by Cockroft-Gault equation for serum creatinine.
• Known to have a condition that in the Investigator's judgment precludes participation in the study.

Sponsors & Collaborators

• Analgesic Solutions: lead
• Grünenthal GmbH: collaborator

Study Sites (1)

Analgesic Solutions

Natick, Massachusetts, 01760, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Stephen Wright, MD

  Analgesic Solutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: July 25, 2016
• Study Start: August 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 25, 2016

Record last verified: 2016-07

Locations

US (1)