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

Pain Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375960
• Other study ID #: V3381-2DPNP01
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2006
• Last updated: March 30, 2007
• Start date: June 2006
• Est. completion date: April 2007

Study information

• Verified date: March 2007
• Source: Vernalis (R&D) Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuralgia
• Pain

Intervention

Drug:
• V3381

• Placebo

Locations

Country	Name	City	State
Canada	LMC Endocrinology Centres Ltd.	Thornhill	Ontario
United States	Translational Pain Research Group, Brigham & Women's Hospital	Boston	Massachusetts
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	Diabetes & Glandular Disease Research Associates Inc.	San Antonio	Texas
United States	American Center for Clinical Trials	Southfield	Michigan
United States	Diablo Clinical Research, Inc.	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
Vernalis (R&D) Ltd	Cita NeuroPharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	11 point numerical pain rating scale (NPRS) daily diary
Secondary	Modified Brief Pain Inventory for DPN
Secondary	McGill Pain Questionnaire — Short Form
Secondary	Neuropathic Pain Symptom Inventory
Secondary	Medical Outcomes Survey Short Form - 12, Version 2
Secondary	Patient Global Impression of Change
Secondary	Patient Preference Questionnaire (end of 2nd treatment period only)
Secondary	Clinical Global Impression of Change
Secondary	Additional secondary assessments will be included in the daily diary: consumption of rescue analgesics
Secondary	daily sleep interference score