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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01770964
Recruitment Status : Unknown
Verified January 2013 by Analgesic Solutions.
Recruitment status was:  Recruiting
First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Painful Distal Symmetric Sensorimotor Polyneuropathy Drug: Pregabalin Drug: placebo Behavioral: Training Type A Behavioral: Training Type B Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : December 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. change in pain severity rating [ Time Frame: Screening/Visit 1 (Day 1) and Visit 4 (Day 15-18) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770964


Locations
United States, Massachusetts
St. Elizabeth's Medica Center Recruiting
Brighton, Massachusetts, United States, 02135
Contact: Cameron Keith, BSN, RN    617-789-2763      
Principal Investigator: Frederic J Gerges, MD         
Sub-Investigator: Andrew L Sternlicht, MD         
Sub-Investigator: Magid A Al-Kimawi, MD         
MedVadis Research Corporation Recruiting
Watertown, Massachusetts, United States, 02472
Contact: Alice Brown, MD    617-744-1310      
Sub-Investigator: Alice Brown, MD         
Principal Investigator: Egilius Spierings, MD Phd         
United States, New York
Neuro Care Medical Associates Recruiting
Johnson City, New York, United States, 13790
Contact: Kathe Rooney    607-729-1521 ext 308      
Principal Investigator: Aamir Rasheed, MD         
Sub-Investigator: Taseer Ahmed Minhas, MD         
Sub-Investigator: Sherrie A Adler, FNP         
University of Rochester Recruiting
Rochester, New York, United States, 14618
Contact: Maria Frazer    585-340-8926      
Principal Investigator: Armando A Villarreal, MD         
Sub-Investigator: John D Markman, MD         
United States, Pennsylvania
Blair Medical Associates, Inc. Recruiting
Altoona, Pennsylvania, United States, 16602
Contact: Julia E Benton, RN, CCRC    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         
United States, Rhode Island
Clinical Partners Recruiting
Johnston, Rhode Island, United States, 02919
Contact: Caroline DiGiulio, RN    401-454-3800      
Principal Investigator: Albert J Marano, MD         
Sub-Investigator: William J Beliveau, MD         
Sponsors and Collaborators
Analgesic Solutions
Astellas Pharma Europe B.V.
Pfizer
Investigators
Principal Investigator: Jeremiah J Trudeau, PhD Analgesic Solutions
More Information

Responsible Party: Analgesic Solutions
ClinicalTrials.gov Identifier: NCT01770964     History of Changes
Other Study ID Numbers: ALPMF-0007-2012
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Pain
Diabetic Neuropathies
Polyneuropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Diabetes Complications
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs