Clinical trial NCT00375960: A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Diabetic Neuropathies
Keywords: 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
Lead sponsor: Vernalis (R&D) Ltd
Sponsor class: INDUSTRY
Collaborators: name: Cita NeuroPharmaceuticals
First posted: 2006-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 11 point numerical pain rating scale (NPRS) daily diary
Secondary outcomes:
measure: Modified Brief Pain Inventory for DPN
measure: McGill Pain Questionnaire - Short Form
measure: Neuropathic Pain Symptom Inventory
measure: Medical Outcomes Survey Short Form - 12, Version 2
measure: Patient Global Impression of Change
measure: Patient Preference Questionnaire (end of 2nd treatment period only)
measure: Clinical Global Impression of Change
measure: Additional secondary assessments will be included in the daily diary: consumption of rescue analgesics
measure: daily sleep interference score
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Boston
country: United States
facility: Translational Pain Research Group, Brigham & Women's Hospital
state: Massachusetts
city: Southfield
country: United States
facility: American Center for Clinical Trials
state: Michigan
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Associates Inc.
state: Texas
city: Thornhill
country: Canada
facility: LMC Endocrinology Centres Ltd.
state: Ontario
Study officials:
affiliation: Brigham and Women's Hospital, Harvard Medical School
name: Christine Sang, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: