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

January 16, 2013 updated by: Analgesic Solutions

Evaluation of the Impact of Subject and Staff Training on the Pregabalin vs. Placebo Difference in Subjects With Painful Diabetic Neuropathy (PDN)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Recruiting
        • St. Elizabeth's Medica Center
        • Contact:
          • Cameron Keith, BSN, RN
          • Phone Number: 617-789-2763
        • Principal Investigator:
          • Frederic J Gerges, MD
        • Sub-Investigator:
          • Andrew L Sternlicht, MD
        • Sub-Investigator:
          • Magid A Al-Kimawi, MD
      • Watertown, Massachusetts, United States, 02472
        • Recruiting
        • MedVadis Research Corporation
        • Sub-Investigator:
          • Alice Brown, MD
        • Contact:
          • Alice Brown, MD
          • Phone Number: 617-744-1310
        • Principal Investigator:
          • Egilius Spierings, MD Phd
    • New York
      • Johnson City, New York, United States, 13790
        • Recruiting
        • Neuro Care Medical Associates
        • Contact:
          • Kathe Rooney
          • Phone Number: 308 607-729-1521
        • Principal Investigator:
          • Aamir Rasheed, MD
        • Sub-Investigator:
          • Taseer Ahmed Minhas, MD
        • Sub-Investigator:
          • Sherrie A Adler, FNP
      • Rochester, New York, United States, 14618
        • Recruiting
        • University of Rochester
        • Contact:
          • Maria Frazer
          • Phone Number: 585-340-8926
        • Principal Investigator:
          • Armando A Villarreal, MD
        • Sub-Investigator:
          • John D Markman, MD
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Recruiting
        • Blair Medical Associates, Inc.
        • Contact:
          • Julia E Benton, RN, CCRC
          • Phone Number: 814-946-7569
        • Principal Investigator:
          • Anthony J Bartkowiak, Jr., MD, FACP, CPI
        • Sub-Investigator:
          • Jessica L Dilling, CRNP
        • Sub-Investigator:
          • Andrea Jill Runk, CRNP
        • Sub-Investigator:
          • Harry L Penny, DPM
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Recruiting
        • Clinical Partners
        • Contact:
          • Caroline DiGiulio, RN
          • Phone Number: 401-454-3800
        • Principal Investigator:
          • Albert J Marano, MD
        • Sub-Investigator:
          • William J Beliveau, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Training Type A, pregabalin
Subjects randomized to receive pregabalin at a site that received training Type A
Drug: Pregabalin
Behavioral: Training Type A
Other: Training Type B, pregabalin
Subjects randomized to receive pregabalin at a site that received training Type B
Drug: Pregabalin
Behavioral: Training Type B
Other: Training Type A, placebo
Subjects randomized to receive placebo at a site that received training Type A
Drug: placebo
Behavioral: Training Type A
Other: Training Type B, placebo
Subjects randomized to receive placebo at a site that received training Type B
Drug: placebo
Behavioral: Training Type B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in pain severity rating
Time Frame: Screening/Visit 1 (Day 1) and Visit 4 (Day 15-18)
Screening/Visit 1 (Day 1) and Visit 4 (Day 15-18)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Analgesic Solutions

Collaborators

Pfizer
Astellas Pharma Europe B.V.

Investigators

  • Principal Investigator: Jeremiah J Trudeau, PhD, Analgesic Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

December 13, 2012

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALPMF-0007-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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