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)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Vernalis (R&D) Ltd
- Enrollment
- 50
- Locations
- 6
- Primary Endpoint
- 11 point numerical pain rating scale (NPRS) daily diary
- Status
- Completed
- Last Updated
- 19 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
11 point numerical pain rating scale (NPRS) daily diary
Secondary Outcomes
- 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