Back to resultsA Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain
Primary Purpose
Pain, Diabetic Neuropathies
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
V3381
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring 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
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
Sites / Locations
- Diablo Clinical Research, Inc.
- Clinical Research of West Florida, Inc.
- Translational Pain Research Group, Brigham & Women's Hospital
- American Center for Clinical Trials
- Diabetes & Glandular Disease Research Associates Inc.
- LMC Endocrinology Centres Ltd.
Outcomes
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
Full Information
NCT ID
NCT00375960
First Posted
September 11, 2006
Last Updated
March 30, 2007
Sponsor
Vernalis (R&D) Ltd
Collaborators
Cita NeuroPharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00375960
Brief Title
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
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Vernalis (R&D) Ltd
Collaborators
Cita NeuroPharmaceuticals
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
V3381
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
11 point numerical pain rating scale (NPRS) daily diary
Secondary Outcome Measure Information:
Title
Modified Brief Pain Inventory for DPN
Title
McGill Pain Questionnaire - Short Form
Title
Neuropathic Pain Symptom Inventory
Title
Medical Outcomes Survey Short Form - 12, Version 2
Title
Patient Global Impression of Change
Title
Patient Preference Questionnaire (end of 2nd treatment period only)
Title
Clinical Global Impression of Change
Title
Additional secondary assessments will be included in the daily diary: consumption of rescue analgesics
Title
daily sleep interference score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Sang, M.D., MPH
Organizational Affiliation
Brigham and Women's Hospital, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Translational Pain Research Group, Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
American Center for Clinical Trials
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Diabetes & Glandular Disease Research Associates Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78299-4801
Country
United States
Facility Name
LMC Endocrinology Centres Ltd.
City
Thornhill
State/Province
Ontario
ZIP/Postal Code
L4J 8L7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain
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