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

Sponsor

Vernalis (R&D) Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT00375960

Collaborator

Cita NeuroPharmaceuticals (Industry)

Enrollment

Locations

Duration (Months)

8.3

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jun 1, 2006

Study Completion Date :

Apr 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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