Recruiting

Painful Diabetic Neuropathy

Sponsor:

Analgesic Solutions

Code:

NCT01770964

Conditions

Diabetes Mellitus

Painful Distal Symmetric Sensorimotor Polyneuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pregabalin

placebo

Training Type A

Training Type B

Study Details

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

Study ID

NCT01770964

Start date

Dec, 2012

Status verified date

Jan, 2013

Completion date

Jul, 2013

Anticipated

Primary completion date

Jul, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Training Type A, pregabalin

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

other: Training Type B, pregabalin

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

other: Training Type A, placebo

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

other: Training Type B, placebo

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

Interventions

Pregabalin

placebo

Training Type A

Training Type B

Primary outcome measure

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

Central Contacts and Locations

Locations

St. Elizabeth's Medica Center

Recruiting

Brighton, Massachusetts, United States, 02135

Contacts

Cameron Keith, BSN, RN

617-789-2763

Principal Investigator:

Frederic J Gerges, MD

MedVadis Research Corporation

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

Alice Brown, MD

617-744-1310

Principal Investigator:

Egilius Spierings, MD Phd

Neuro Care Medical Associates

Recruiting

Johnson City, New York, United States, 13790

Contacts

Kathe Rooney

607-729-1521

Principal Investigator:

Aamir Rasheed, MD

University of Rochester

Recruiting

Rochester, New York, United States, 14618

Contacts

Maria Frazer

585-340-8926

Principal Investigator:

Armando A Villarreal, MD

Blair Medical Associates, Inc.

Recruiting

Altoona, Pennsylvania, United States, 16602

Contacts

Julia E Benton, RN, CCRC

814-946-7569

Principal Investigator:

Anthony J Bartkowiak, Jr., MD, FACP, CPI

Clinical Partners

Recruiting

Johnston, Rhode Island, United States, 02919

Contacts

Caroline DiGiulio, RN

401-454-3800

Principal Investigator:

Albert J Marano, MD

More Information

Sponsor

Analgesic Solutions

Last update posted

Jan 18, 2013

Last verified

Jan, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Analgesic Solutions on 2013-01-18.