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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

Tracking Information
First Submitted Date  ICMJE August 21, 2013
First Posted Date  ICMJE July 25, 2016
Last Update Posted Date July 25, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Training "Pain Connoisseurs" for Efficient Analgesic Proof-of-Concept Studies
Official Title  ICMJE Training "Pain Connoisseurs" for Efficient Analgesic Proof-of-Concept Studies
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Painful Diabetic Neuropathy (PDN)
Intervention  ICMJE
  • Other: EPT
  • Drug: Drug Placebo Administration
  • Other: C
    No Intervention
    Other Name: Control
Study Arms  ICMJE
  • DPA
    Drug Placebo Administration
    Intervention: Drug: Drug Placebo Administration
  • C
    Control
    Intervention: Other: C
  • EPT
    Evoked Pain Training
    Intervention: Other: EPT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2016)
98
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02842554
Other Study ID Numbers  ICMJE GRN.PC.002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Analgesic Solutions
Study Sponsor  ICMJE Analgesic Solutions
Collaborators  ICMJE Grünenthal GmbH
Investigators  ICMJE
Principal Investigator: Stephen Wright, MD Analgesic Solutions
PRS Account Analgesic Solutions
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP