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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Analgesic Solutions
Sponsor:
Collaborators:
Astellas Pharma Europe B.V.
Pfizer
Information provided by (Responsible Party):
Analgesic Solutions
ClinicalTrials.gov Identifier:
NCT01770964
First received: December 13, 2012
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Diabetes Mellitus
Painful Distal Symmetric Sensorimotor Polyneuropathy
Drug: Pregabalin
Drug: placebo
Behavioral: Training Type A
Behavioral: Training Type B
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Analgesic Solutions:

Primary Outcome Measures:
  • change in pain severity rating [ Time Frame: Screening/Visit 1 (Day 1) and Visit 4 (Day 15-18) ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Analgesic Solutions
ClinicalTrials.gov Identifier: NCT01770964     History of Changes
Other Study ID Numbers: ALPMF-0007-2012
Study First Received: December 13, 2012
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Neuropathies
Pain
Polyneuropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 22, 2014