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CompletedNCT00375960Updated Apr 2, 2007

A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain

A Phase 2 interventional study of V3381 and Placebo in Pain and Diabetic Neuropathies, sponsored by Vernalis (R&D) Ltd. Completed at 6 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-04-02.

Sponsored by Vernalis (R&D) Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

Diabetic Peripheral Neuropathic Pain (DPNP) is pain in your feet and legs, or even in your hands and arms, sometimes experienced by people with diabetes. Neuropathic pain syndromes are much more common than is perhaps generally recognized. Approximately 1% of the population in western countries suffers from neuropathic pain. Some clinical conditions are associated with a relatively high incidence of neuropathic pain. Approximately 15% of patients with diabetic neuropathy have persistent neuropathic pain in the feet, legs and hands.

02

Conditions studied

  • Pain
  • Diabetic Neuropathies

Keywords

  • Pain associated with diabetes Type I or Type II
  • Neuropathic Pain due to diabetes
  • Diabetic peripheral neuropathic pain
  • Pain
  • Diabetes with burning sensation in the arms and/or legs
  • Diabetes with tingling sensation in the arms and/or legs
  • Neuropathic Pain Due to Diabetes Type I or Type II
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 50 is close to the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Vernalis (R&D) Ltd is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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%
  • Known seizure disorder
  • Any malignancy in the past 2 years (with the exception of basal cell carcinoma)
  • Pain that cannot be clearly differentiated from, or conditions that interfere with the assessment of diabetic neuropathic pain.
  • Use of anticonvulsants, antidepressants, or prescription membrane-stabilizing agents
  • History of substance abuse or dependence within the past year, excluding nicotine and caffeine
  • Frequent and/or severe allergic reactions with multiple medications
  • Participation in any clinical trial within 30 days before screening
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
50 participants

Interventions

  • DrugV3381
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. 11 point numerical pain rating scale (NPRS) daily diary

Secondary outcomes

  1. Modified Brief Pain Inventory for DPN

  2. McGill Pain Questionnaire - Short Form

  3. Neuropathic Pain Symptom Inventory

  4. Medical Outcomes Survey Short Form - 12, Version 2

  5. Patient Global Impression of Change

  6. Patient Preference Questionnaire (end of 2nd treatment period only)

  7. Clinical Global Impression of Change

  8. Additional secondary assessments will be included in the daily diary: consumption of rescue analgesics

  9. daily sleep interference score

07

Study locations

6 sites
  • Diablo Clinical Research, Inc.
    Walnut Creek, California 94598, United States
  • Clinical Research of West Florida, Inc.
    Clearwater, Florida 33765, United States
  • Translational Pain Research Group, Brigham & Women's Hospital
    Boston, Massachusetts 02115, United States
  • American Center for Clinical Trials
    Southfield, Michigan 48034, United States
  • Diabetes & Glandular Disease Research Associates Inc.
    San Antonio, Texas 78299-4801, United States
  • LMC Endocrinology Centres Ltd.
    Thornhill, Ontario L4J 8L7, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00375960
Lead sponsor
Vernalis (R&D) Ltd
Collaborators
Cita NeuroPharmaceuticals
First posted
Sep 13, 2006
Start date
Jun 2006
Completion
Apr 2007
Last update
Apr 2, 2007

Study contacts

Christine Sang, M.D., MPH
principal investigator · Brigham and Women's Hospital, Harvard Medical School
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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