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

This study has been completed.
Sponsor:
Collaborator:
Cita NeuroPharmaceuticals
Information provided by:
Vernalis (R&D) Ltd
ClinicalTrials.gov Identifier:
NCT00375960
First received: September 11, 2006
Last updated: March 30, 2007
Last verified: March 2007
  Purpose

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 Intervention Phase
Pain
Diabetic Neuropathies
Drug: V3381
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Vernalis (R&D) Ltd:

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

Secondary Outcome Measures:
  • 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
  • Patient Preference Questionnaire (end of 2nd treatment period only)
  • Clinical Global Impression of Change
  • Additional secondary assessments will be included in the daily diary: consumption of rescue analgesics
  • daily sleep interference score

Estimated Enrollment: 50
Study Start Date: June 2006
Estimated Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375960

Locations
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
Investigators
Principal Investigator: Christine Sang, M.D., MPH Brigham and Women's Hospital, Harvard Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00375960     History of Changes
Other Study ID Numbers: V3381-2DPNP01
Study First Received: September 11, 2006
Last Updated: March 30, 2007
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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
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
Diabetic Peripheral Neuropathic Pain

Additional relevant MeSH terms:
Neuralgia
Diabetic Neuropathies
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014