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

Vernalis Therapeutics

Status and phase

Completed

Phase 2

Conditions

Diabetic Neuropathies

Pain

Treatments

Drug: Placebo

Drug: V3381

Study type

Interventional

Funder types

Industry

Identifiers

NCT00375960

V3381-2DPNP01

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No 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