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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00375960
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : April 2, 2007
Cita NeuroPharmaceuticals
Information provided by:
Vernalis (R&D) Ltd

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.

Condition or disease Intervention/treatment Phase
Pain Diabetic Neuropathies Drug: V3381 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Crossover Study of the Safety, Efficacy and Pharmacokinetics of Two Escalating, Oral Doses of V3381 (200 mg BID and 400 mg BID) for 28 Days in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Study Start Date : June 2006
Study Completion Date : April 2007

Primary Outcome Measures :
  1. 11 point numerical pain rating scale (NPRS) daily diary

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00375960

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United States, California
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, Florida
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
United States, Massachusetts
Translational Pain Research Group, Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
American Center for Clinical Trials
Southfield, Michigan, United States, 48034
United States, Texas
Diabetes & Glandular Disease Research Associates Inc.
San Antonio, Texas, United States, 78299-4801
Canada, Ontario
LMC Endocrinology Centres Ltd.
Thornhill, Ontario, Canada, L4J 8L7
Sponsors and Collaborators
Vernalis (R&D) Ltd
Cita NeuroPharmaceuticals
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Principal Investigator: Christine Sang, M.D., MPH Brigham and Women's Hospital, Harvard Medical School
Layout table for additonal information Identifier: NCT00375960    
Other Study ID Numbers: V3381-2DPNP01
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: April 2, 2007
Last Verified: March 2007
Keywords provided by Vernalis (R&D) Ltd:
Pain associated with diabetes Type I or Type II
Neuropathic Pain due to diabetes
Diabetic peripheral neuropathic 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
Additional relevant MeSH terms:
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Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases