NCT00375960

Brief Summary

The objective of this study is to investigate the safety and efficacy of an investigational drug, V3381, for the treatment of diabetic peripheral neuropathic (DPN) pain (pain in one's feet and legs, or even in one's hands and arms, sometimes experienced by people with diabetes). An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) and/or Health Canada.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 pain

Timeline
Completed

Started Jun 2006

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 2, 2007

Status Verified

March 1, 2007

First QC Date

September 11, 2006

Last Update Submit

March 30, 2007

Conditions

PainDiabetic Neuropathies

Keywords

Pain associated with diabetes Type I or Type IINeuropathic Pain due to diabetesDiabetic peripheral neuropathic painPainDiabetes with burning sensation in the arms and/or legsDiabetes with tingling sensation in the arms and/or legsNeuropathic Pain Due to Diabetes Type I or Type II

Outcome Measures

Primary Outcomes (1)

  • 11 point numerical pain rating scale (NPRS) daily diary

Secondary Outcomes (9)

  • Modified Brief Pain Inventory for DPN

  • McGill Pain Questionnaire - Short Form

  • Neuropathic Pain Symptom Inventory

  • Medical Outcomes Survey Short Form - 12, Version 2

  • Patient Global Impression of Change

  • +4 more secondary outcomes

Interventions

V3381DRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females 18-75 years of age
  • Diabetes mellitus (type I or type II)
  • No change in medications for reducing blood sugar within 4 weeks before screening
  • Experiencing daily pain due to diabetic neuropathy for at least 6 months but not more than 5 years
  • Neuropathic pain must begin in the feet, with relatively symmetrical onset.
  • Willing to perform self-monitoring of blood glucose
  • Able to communicate intelligibly with the investigator and study coordinator
  • Keeping all appointments for clinic visits, tests, and procedures

You may not qualify if:

  • Any clinically significant neurologic disorders (with the exception of diabetic peripheral neuropathic pain)
  • Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study
  • Prior renal transplant or current renal dialysis
  • Pernicious anemia
  • Untreated hypothyroidism
  • Amputations due to diabetes mellitus (with the exception of toes)
  • Any clinically significant abnormal electrocardiogram (ECG)
  • Any history of cardiac arrhythmia
  • History of myocardial infarction
  • Active angina
  • Uncontrolled hypertension (i.e., \> 140/90 mm Hg)
  • Known or at high risk of hepatitis B or C infection
  • Known or at high risk of human immunodeficiency virus (HIV) infection
  • Any anticipated need for surgery during the study
  • Glycosylated hemoglobin (HbA1c) \> 9%
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

Translational Pain Research Group, Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

American Center for Clinical Trials

Southfield, Michigan, 48034, United States

Location

Diabetes & Glandular Disease Research Associates Inc.

San Antonio, Texas, 78299-4801, United States

Location

LMC Endocrinology Centres Ltd.

Thornhill, Ontario, L4J 8L7, Canada

Location

MeSH Terms

Conditions

PainDiabetic Neuropathies

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Christine Sang, M.D., MPH

    Brigham and Women's Hospital, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 13, 2006

Study Start

June 1, 2006

Study Completion

April 1, 2007

Last Updated

April 2, 2007

Record last verified: 2007-03

Locations

US(5)CA(1)