- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00375960
A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain
March 30, 2007 updated by: Vernalis (R&D) Ltd
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Thornhill, Ontario, Canada, L4J 8L7
- LMC Endocrinology Centres Ltd.
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-
-
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California
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Walnut Creek, California, United States, 94598
- Diablo Clinical Research, Inc.
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Florida
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Clearwater, Florida, United States, 33765
- Clinical Research of West Florida, Inc.
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Translational Pain Research Group, Brigham & Women's Hospital
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Michigan
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Southfield, Michigan, United States, 48034
- American Center for Clinical Trials
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Texas
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San Antonio, Texas, United States, 78299-4801
- Diabetes & Glandular Disease Research Associates Inc.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
11 point numerical pain rating scale (NPRS) daily diary
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Secondary Outcome Measures
Outcome Measure |
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Patient Global Impression of Change
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Clinical Global Impression of Change
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Neuropathic Pain Symptom Inventory
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Modified Brief Pain Inventory for DPN
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McGill Pain Questionnaire - Short Form
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Medical Outcomes Survey Short Form - 12, Version 2
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Patient Preference Questionnaire (end of 2nd treatment period only)
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Additional secondary assessments will be included in the daily diary: consumption of rescue analgesics
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daily sleep interference score
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine Sang, M.D., MPH, Brigham and Women's Hospital, Harvard Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Study Completion
April 1, 2007
Study Registration Dates
First Submitted
September 11, 2006
First Submitted That Met QC Criteria
September 11, 2006
First Posted (Estimate)
September 13, 2006
Study Record Updates
Last Update Posted (Estimate)
April 2, 2007
Last Update Submitted That Met QC Criteria
March 30, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- V3381-2DPNP01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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