Status:
COMPLETED
Study of the Safety, Tolerability and Efficacy of V3381 in Patients With Diabetic Peripheral Neuropathic Pain
Lead Sponsor:
Vernalis (R&D) Ltd
Conditions:
Diabetic Peripheral Neuropathic Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Randomised, double-blind, placebo-controlled, parallel group, multicentre study of oral doses of V3381, titrated to effect. A 2-week single-blind run-in period will be followed by a 13 week double-bli...
Detailed Description
Patients who provide written informed consent will be screened for entry into the study. Patients will initially enter a 2-week single-blind run-in phase, during which they will complete an 11 point ...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Male or female aged 18 - 75 (18-65 Czech Republic)
- Diagnosis of diabetes mellitus
- No change in diabetes medications within 4 weeks before screening
- Daily pain attributed to diabetic neuropathy present for at least 6 months immediately prior to study entry
- Presents with pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes mellitus. Pain must have begun in the feet, with relatively symmetrical onset. Diagnosis confirmed by a score of at least 2 on Section B of the MNSI
- Judged to be reliable and agree to keep all appointments required by the protocol
- Females should be of non child-bearing potential (i.e. surgically sterilized or \>1 year post-menopause). Male subjects who are sexually active with a female partner of child bearing potential must agree to use a barrier method of contraception (eg condom, diaphragm or cervical cap in the female female partner) for the duration of the study (until the follow up visit)
- Additionally, at the baseline visit:
- A mean average pain intensity of at least 4, but less than or equal to 9, on an 11 point Likert NPRS recorded twice daily during the two week placebo run-in; any patient who experiences a \>30% decrease in the mean pain score compared to Day -14 during placebo run-in will be excluded, regardless of whether their final score is \>4
- Full completion of daily diaries for at least 11 of the days up to Day -1
- Compliance in taking placebo run-in medication twice daily for at least 11 of the days up to Day -1
Exclusion
- Any clinically significant neurologic disorders (except DPNP)
- Any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study
- Prior renal transplant, current renal dialysis
- Pernicious anemia
- Untreated hypothyroidism
- Amputations or persistent ulceration due to diabetes mellitus
- Any cardiovascular condition that would contraindicate the use of sympathomimetic amines
- Uncontrolled hypertension
- Known or at high risk of HIV infection
- Any anticipated need for surgery during the study
- Increased risk of seizures (defined as a history of seizure disorder (including alcoholic seizures), family history of seizures and history of head trauma that resulted in loss of consciousness or concussion).
- Any malignancy in the past 2 years (except 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 (particularly MAO inhibitors), or prescription membrane-stabilizing agents, including topical therapies. Patients currently taking drugs in these classes may have them discontinued prior to entry into the placebo run-in period.
- Use of opioids, especially meperidine (pethidine)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT00794430
Start Date
December 1 2008
End Date
December 1 2009
Last Update
June 3 2016
Active Locations (31)
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1
Clinical Trials Inc
Little Rock, Arkansas, United States, 72205
2
Renstar Inc
Ocala, Florida, United States, 34471
3
Radiant Research Inc
St. Petersburg, Florida, United States, 33781
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115