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

NCT01770964 | Unknown Phase 4

• 1 other identifier: ALPMF-0007-2012
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 6

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.

Conditions

Diabetes Mellitus; Painful Distal Symmetric Sensorimotor Polyneuropathy

Outcome Measures

Primary Outcomes (1)

• change in pain severity rating

  Screening/Visit 1 (Day 1) and Visit 4 (Day 15-18)

Study Arms (4)

Training Type A, pregabalin

OTHER

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

Drug: Pregabalin; Behavioral: Training Type A

Training Type B, pregabalin

OTHER

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

Drug: Pregabalin; Behavioral: Training Type B

Training Type A, placebo

OTHER

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

Drug: placebo; Behavioral: Training Type A

Training Type B, placebo

OTHER

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

Drug: placebo; Behavioral: Training Type B

Interventions

Pregabalin DRUG

Training Type A, pregabalin; Training Type B, pregabalin

placebo DRUG

Training Type A, placebo; Training Type B, placebo

Training Type A BEHAVIORAL

Training Type A, placebo; Training Type A, pregabalin

Training Type B BEHAVIORAL

Training Type B, placebo; Training Type B, pregabalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Analgesic Solutions: lead
• Astellas Pharma Europe B.V.: collaborator
• Pfizer: collaborator

Study Sites (6)

St. Elizabeth's Medica Center

Brighton, Massachusetts, 02135, United States

RECRUITING

MedVadis Research Corporation

Watertown, Massachusetts, 02472, United States

RECRUITING

Neuro Care Medical Associates

Johnson City, New York, 13790, United States

RECRUITING

University of Rochester

Rochester, New York, 14618, United States

RECRUITING

Blair Medical Associates, Inc.

Altoona, Pennsylvania, 16602, United States

RECRUITING

Clinical Partners

Johnston, Rhode Island, 02919, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jeremiah J Trudeau, PhD

  Analgesic Solutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: January 18, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 18, 2013

Record last verified: 2013-01

Locations

US (6)