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

Primary Purpose

Diabetes Mellitus, Painful Distal Symmetric Sensorimotor Polyneuropathy

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pregabalin
placebo
Training Type A
Training Type B
Sponsored by
Analgesic Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Elizabeth's Medica CenterRecruiting
  • MedVadis Research CorporationRecruiting
  • Neuro Care Medical AssociatesRecruiting
  • University of RochesterRecruiting
  • Blair Medical Associates, Inc.Recruiting
  • Clinical PartnersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Training Type A, pregabalin

Training Type B, pregabalin

Training Type A, placebo

Training Type B, placebo

Arm Description

Subjects randomized to receive pregabalin at a site that received training Type A

Subjects randomized to receive pregabalin at a site that received training Type B

Subjects randomized to receive placebo at a site that received training Type A

Subjects randomized to receive placebo at a site that received training Type B

Outcomes

Primary Outcome Measures

change in pain severity rating

Secondary Outcome Measures

Full Information

First Posted
December 13, 2012
Last Updated
January 16, 2013
Sponsor
Analgesic Solutions
Collaborators
Astellas Pharma Europe B.V., Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01770964
Brief Title
Evaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neuropathy
Official Title
Evaluation of the Impact of Subject and Staff Training on the Pregabalin vs. Placebo Difference in Subjects With Painful Diabetic Neuropathy (PDN)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Analgesic Solutions
Collaborators
Astellas Pharma Europe B.V., Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Painful Distal Symmetric Sensorimotor Polyneuropathy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training Type A, pregabalin
Arm Type
Other
Arm Description
Subjects randomized to receive pregabalin at a site that received training Type A
Arm Title
Training Type B, pregabalin
Arm Type
Other
Arm Description
Subjects randomized to receive pregabalin at a site that received training Type B
Arm Title
Training Type A, placebo
Arm Type
Other
Arm Description
Subjects randomized to receive placebo at a site that received training Type A
Arm Title
Training Type B, placebo
Arm Type
Other
Arm Description
Subjects randomized to receive placebo at a site that received training Type B
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Type
Behavioral
Intervention Name(s)
Training Type A
Intervention Type
Behavioral
Intervention Name(s)
Training Type B
Primary Outcome Measure Information:
Title
change in pain severity rating
Time Frame
Screening/Visit 1 (Day 1) and Visit 4 (Day 15-18)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremiah J Trudeau, PhD
Organizational Affiliation
Analgesic Solutions
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Elizabeth's Medica Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cameron Keith, BSN, RN
Phone
617-789-2763
First Name & Middle Initial & Last Name & Degree
Frederic J Gerges, MD
First Name & Middle Initial & Last Name & Degree
Andrew L Sternlicht, MD
First Name & Middle Initial & Last Name & Degree
Magid A Al-Kimawi, MD
Facility Name
MedVadis Research Corporation
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Brown, MD
Phone
617-744-1310
First Name & Middle Initial & Last Name & Degree
Alice Brown, MD
First Name & Middle Initial & Last Name & Degree
Egilius Spierings, MD Phd
Facility Name
Neuro Care Medical Associates
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathe Rooney
Phone
607-729-1521
Ext
308
First Name & Middle Initial & Last Name & Degree
Aamir Rasheed, MD
First Name & Middle Initial & Last Name & Degree
Taseer Ahmed Minhas, MD
First Name & Middle Initial & Last Name & Degree
Sherrie A Adler, FNP
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Frazer
Phone
585-340-8926
First Name & Middle Initial & Last Name & Degree
Armando A Villarreal, MD
First Name & Middle Initial & Last Name & Degree
John D Markman, MD
Facility Name
Blair Medical Associates, Inc.
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia E Benton, RN, CCRC
Phone
814-946-7569
First Name & Middle Initial & Last Name & Degree
Anthony J Bartkowiak, Jr., MD, FACP, CPI
First Name & Middle Initial & Last Name & Degree
Jessica L Dilling, CRNP
First Name & Middle Initial & Last Name & Degree
Andrea Jill Runk, CRNP
First Name & Middle Initial & Last Name & Degree
Harry L Penny, DPM
Facility Name
Clinical Partners
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline DiGiulio, RN
Phone
401-454-3800
First Name & Middle Initial & Last Name & Degree
Albert J Marano, MD
First Name & Middle Initial & Last Name & Degree
William J Beliveau, MD

12. IPD Sharing Statement

Learn more about this trial

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

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