Evaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neuropathy

NCT01770964

Last updated date
Study Location
St. Elizabeth's Medica Center
Brighton, Massachusetts, 02135, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus, Painful Distal Symmetric Sensorimotor Polyneuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Willingly signs and dates an Informed Consent Form (ICF) that is approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), prior to the conduct of any study-specific procedures;

- Is at least 18 years old;

- Has a diagnosis of type 1 or type 2 diabetes and painful distal symmetric sensorimotor polyneuropathy;

- Has experienced a minimum duration of PDN of at least 6 months;

- Is on stable diabetic medication that is not expected to change during the study;

- Has a worst pain intensity over the past 24 hours as a 4 or higher on a 0-10 numerical rating scale at Screening;

- And is able to read and communicate meaningfully in English and comply with all study procedures

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Has a psychiatric or psychological disorder that in the judgment of the Investigator
would interfere with the completion of the study, confound the study results, or pose
subject risk;


- Has an uncontrolled, clinically significant medical condition that in the judgment of
the Investigator may contraindicate use of pregabalin or participation in the study
(e.g., hepatic, respiratory, or hematologic illness; cardiovascular disease; or
symptomatic peripheral vascular disease);


- Has experience as an investigator or a study staff member in clinical trials research
in a role that involved direct patient contact;


- Participated in any of the following studies: Analgesic Solutions Protocol #
ALPMF.SOW.0007, Analgesic Solutions Protocol # ALPMF.SOW.0007.02, or Astellas Protocol
# E05-CL-3004;


- Has pain of other origin that might confound assessment of PDN;


- Has major skin ulceration;


- Has had an amputation other than toes;


- Has a history of suicide attempt within the past 1 year;


- Reports current suicidal ideation within the past 1month;


- Has history of kidney disease that is likely to decrease creatinine clearance;


- Has creatinine clearance below 60 as calculated by Cockroft-Gault equation for serum
creatinine;


- Has a history of drug or alcohol abuse within the past 1 year;


- Has hypersensitivity, intolerance, or allergy to pregabalin or gabapentin;


- Subject is pregnant, is considering becoming pregnant during the study, is
breastfeeding or unwilling to use adequate birth control during the study;


- Participated in another clinical trial within the past month;


- Is involved in an ongoing or settled worker's compensation claim, disability, or
litigation;


- Has a known failure to respond to pregabalin or gabapentin at a clinically relevant
dose due to either efficacy or tolerability;


- Or has taken opioids on an as-needed basis within 1week of Screening, or has taken
pregabalin or gabapentin within 30 days of screening. Subjects on stable doses
opioids, antidepressants, non-steroidal anti-inflammatory drugs, or low-dose aspirin
will be allowed to participate in the study

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Diabetes Mellitus, Painful Distal Symmetric Sensorimotor PolyneuropathyEvaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neuropathy
NCT01770964
  1. Brighton, Massachusetts
  2. Watertown, Massachusetts
  3. Johnson City, New York
  4. Rochester, New York
  5. Altoona, Pennsylvania
  6. Johnston, Rhode Island
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neuropathy
Official Title  ICMJE Evaluation of the Impact of Subject and Staff Training on the Pregabalin vs. Placebo Difference in Subjects With Painful Diabetic Neuropathy (PDN)
Brief Summary The difference between active treatment and placebo in a clinical trial of an analgesic appears to depend on a variety of factors other than the actual efficacy of the drug itself, including various aspects of study design and conduct. One potential such factor is how information about the study is presented to research staff and patients. The purpose of this study is to examine the impact of different presentations of information on the difference between pregabalin and placebo observed in a clinical trial in patients with painful diabetic neuropathy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Diabetes Mellitus
  • Painful Distal Symmetric Sensorimotor Polyneuropathy
Intervention  ICMJE
  • Drug: Pregabalin
  • Drug: placebo
  • Behavioral: Training Type A
  • Behavioral: Training Type B
Study Arms  ICMJE
  • Training Type A, pregabalin
    Subjects randomized to receive pregabalin at a site that received training Type A
    Interventions:
    • Drug: Pregabalin
    • Behavioral: Training Type A
  • Training Type B, pregabalin
    Subjects randomized to receive pregabalin at a site that received training Type B
    Interventions:
    • Drug: Pregabalin
    • Behavioral: Training Type B
  • Training Type A, placebo
    Subjects randomized to receive placebo at a site that received training Type A
    Interventions:
    • Drug: placebo
    • Behavioral: Training Type A
  • Training Type B, placebo
    Subjects randomized to receive placebo at a site that received training Type B
    Interventions:
    • Drug: placebo
    • Behavioral: Training Type B
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 16, 2013)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Willingly signs and dates an Informed Consent Form (ICF) that is approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), prior to the conduct of any study-specific procedures;
  • Is at least 18 years old;
  • Has a diagnosis of type 1 or type 2 diabetes and painful distal symmetric sensorimotor polyneuropathy;
  • Has experienced a minimum duration of PDN of at least 6 months;
  • Is on stable diabetic medication that is not expected to change during the study;
  • Has a worst pain intensity over the past 24 hours as a 4 or higher on a 0-10 numerical rating scale at Screening;
  • And is able to read and communicate meaningfully in English and comply with all study procedures

Exclusion Criteria:

  • Has a psychiatric or psychological disorder that in the judgment of the Investigator would interfere with the completion of the study, confound the study results, or pose subject risk;
  • Has an uncontrolled, clinically significant medical condition that in the judgment of the Investigator may contraindicate use of pregabalin or participation in the study (e.g., hepatic, respiratory, or hematologic illness; cardiovascular disease; or symptomatic peripheral vascular disease);
  • Has experience as an investigator or a study staff member in clinical trials research in a role that involved direct patient contact;
  • Participated in any of the following studies: Analgesic Solutions Protocol # ALPMF.SOW.0007, Analgesic Solutions Protocol # ALPMF.SOW.0007.02, or Astellas Protocol # E05-CL-3004;
  • Has pain of other origin that might confound assessment of PDN;
  • Has major skin ulceration;
  • Has had an amputation other than toes;
  • Has a history of suicide attempt within the past 1 year;
  • Reports current suicidal ideation within the past 1month;
  • Has history of kidney disease that is likely to decrease creatinine clearance;
  • Has creatinine clearance below 60 as calculated by Cockroft-Gault equation for serum creatinine;
  • Has a history of drug or alcohol abuse within the past 1 year;
  • Has hypersensitivity, intolerance, or allergy to pregabalin or gabapentin;
  • Subject is pregnant, is considering becoming pregnant during the study, is breastfeeding or unwilling to use adequate birth control during the study;
  • Participated in another clinical trial within the past month;
  • Is involved in an ongoing or settled worker's compensation claim, disability, or litigation;
  • Has a known failure to respond to pregabalin or gabapentin at a clinically relevant dose due to either efficacy or tolerability;
  • Or has taken opioids on an as-needed basis within 1week of Screening, or has taken pregabalin or gabapentin within 30 days of screening. Subjects on stable doses opioids, antidepressants, non-steroidal anti-inflammatory drugs, or low-dose aspirin will be allowed to participate in the study
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 NCT01770964
Other Study ID Numbers  ICMJE ALPMF-0007-2012
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
  • Astellas Pharma Europe B.V.
  • Pfizer
Investigators  ICMJE
Principal Investigator:Jeremiah J Trudeau, PhDAnalgesic Solutions
PRS Account Analgesic Solutions
Verification Date January 2013

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