Evaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neuropathy
NCT ID: NCT01770964
Last Updated: 2013-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2012-12-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Training Type A, pregabalin
Subjects randomized to receive pregabalin at a site that received training Type A
Pregabalin
Training Type A
Training Type B, pregabalin
Subjects randomized to receive pregabalin at a site that received training Type B
Pregabalin
Training Type B
Training Type A, placebo
Subjects randomized to receive placebo at a site that received training Type A
placebo
Training Type A
Training Type B, placebo
Subjects randomized to receive placebo at a site that received training Type B
placebo
Training Type B
Interventions
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Pregabalin
placebo
Training Type A
Training Type B
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Pfizer
INDUSTRY
Analgesic Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Jeremiah J Trudeau, PhD
Role: PRINCIPAL_INVESTIGATOR
Analgesic Solutions
Locations
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St. Elizabeth's Medica Center
Brighton, Massachusetts, United States
MedVadis Research Corporation
Watertown, Massachusetts, United States
Neuro Care Medical Associates
Johnson City, New York, United States
University of Rochester
Rochester, New York, United States
Blair Medical Associates, Inc.
Altoona, Pennsylvania, United States
Clinical Partners
Johnston, Rhode Island, United States
Countries
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Facility Contacts
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Cameron Keith, BSN, RN
Role: primary
Alice Brown, MD
Role: primary
Kathe Rooney
Role: primary
Maria Frazer
Role: primary
Julia E Benton, RN, CCRC
Role: primary
Caroline DiGiulio, RN
Role: primary
Other Identifiers
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ALPMF-0007-2012
Identifier Type: -
Identifier Source: org_study_id
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