Status:
COMPLETED
A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain
Lead Sponsor:
Vernalis (R&D) Ltd
Collaborating Sponsors:
Cita NeuroPharmaceuticals
Conditions:
Pain
Diabetic Neuropathies
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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, o...
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 commo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00375960
Start Date
June 1 2006
End Date
April 1 2007
Last Update
April 2 2007
Active Locations (6)
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1
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
2
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
3
Translational Pain Research Group, Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
4
American Center for Clinical Trials
Southfield, Michigan, United States, 48034