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

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ClinicalTrials.gov Identifier: NCT02842554
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Analgesic Solutions

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.

Condition or disease Intervention/treatment Phase
Painful Diabetic Neuropathy (PDN) Other: EPT Drug: Drug Placebo Administration Other: C Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Training "Pain Connoisseurs" for Efficient Analgesic Proof-of-Concept Studies
Study Start Date : August 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
DPA
Drug Placebo Administration
Drug: Drug Placebo Administration
C
Control
Other: C
No Intervention
Other Name: Control

EPT
Evoked Pain Training
Other: EPT



Primary Outcome Measures :
  1. Pain Assessment Training [ Time Frame: 1 year ]
    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


Secondary Outcome Measures :
  1. Predicted Response to Training [ Time Frame: 1 year ]
    To evaluate whether baseline characteristics of subjects predict response to training, measured by differences in psychophysical profile between baseline and end of study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  10. Have a history of alcohol or other substance abuse (not including nicotine or tobacco) within 5 years.
  11. Have a history of suicide attempt within the past 1 year or suicidal ideation within the past 1 month.
  12. Have a history of epilepsy or other seizure disorder.
  13. Have creatinine clearance below 60 mL/min as calculated by Cockroft-Gault equation for serum creatinine.
  14. Known to have a condition that in the Investigator's judgment precludes participation in the study.
  15. Have previously been admitted to this study.
  16. Are involved in a worker's compensation, disability claim, or litigation related to medical condition or treatment that is open or was settled within the past 12 months. (Whether litigation is related to medical condition or treatment may be decided at the Investigator's discretion. Claims settled >12 months previously are permitted.)
  17. Have a known failure to respond to pregabalin, gabapentin, or oxycodone due to either efficacy or tolerability in previous treatment at therapeutically appropriate doses.
  18. Are allergic to or have a hypersensitivity to pregabalin or oxycodone.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842554


Locations
United States, Massachusetts
Analgesic Solutions
Natick, Massachusetts, United States, 01760
Sponsors and Collaborators
Analgesic Solutions
Grünenthal GmbH
Investigators
Principal Investigator: Stephen Wright, MD Analgesic Solutions

Responsible Party: Analgesic Solutions
ClinicalTrials.gov Identifier: NCT02842554     History of Changes
Other Study ID Numbers: GRN.PC.002
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016

Keywords provided by Analgesic Solutions:
PDN
Painful Diabetic Neuropathy
Diabetes

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs