A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain - Full Text View

Sponsors and Collaborators:	Vernalis (R&D) Ltd Cita NeuroPharmaceuticals
Information provided by:	Vernalis (R&D) Ltd
ClinicalTrials.gov Identifier:	NCT00375960

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 II

MedlinePlus related topics: Diabetes Diabetic Nerve Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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)

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

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

Study ID Numbers:	V3381-2DPNP01
Study First Received:	September 11, 2006
Last Updated:	March 30, 2007
ClinicalTrials.gov Identifier:	NCT00375960
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

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Paresthesia
Diabetes Mellitus

Endocrine System Diseases
Pain
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009