Study of the Safety, Tolerability and Efficacy of V3381 in Patients With Diabetic Peripheral Neuropathic Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Peripheral Neuropathic Pain

In brief

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-blind titration and maintenance phase. Doses will be titrated up in 100 mg bid increments every one or two weeks, starting from 100 mg bid. A 2 week follow-up period will conclude patient participation in the study.

Key facts

Study ID

NCT00794430

Run by

Vernalis (R&D) Ltd

People needed

161

Starts

2008-12-01

Expected to finish

2009-12-01

Last updated by the study team

2016-06-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Clinical Trials Inc — Little Rock, Arkansas, United States
• Renstar Inc — Ocala, Florida, United States
• Radiant Research Inc — St. Petersburg, Florida, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Advanced Biomedical Research of America — Las Vegas, Nevada, United States
• Radiant Research Inc — Cincinnati, Ohio, United States
• Neurology & Neuroscience Center of Ohio — Toledo, Ohio, United States
• dgd Research — San Antonio, Texas, United States
• Endeavor Clinical Trials — San Antonio, Texas, United States
• LMC Endocrinology — Thornhill, Canada
• LMC Endocrinology — Toronto, Canada
• Private Clinic — Brno, Brno, Czechia
• Nemocnice Ceske Budejovice — České Budějovice, Ceske Budejovice, Czechia
• Private Clinic — Holešov, Holesov, Czechia
• Private Clinic — Hranice, Hranice, Czechia
• Smetanovy sady — Karlovy Vary, Karlovy Vary, Czechia
• Neurologicke oddeleni — Pardubice, Pardubice, Czechia
• Private Clinic, Michnova 1622/4 — Prague, Prague, Czechia
• ResTrial s.r.o. — Prague, Prague, Czechia
• Lekarsky dum Ormiga — Zlín, Zlín, Czechia
• Diabetology Center — Zlín, Czechia
• Royal Infirmary of Edinburgh — Edinburgh, Scotland, United Kingdom
• Ipswich Hospital NHS Trust — Ipswich, Suffolk, United Kingdom
• Barnsley Hospital — Barnsley, United Kingdom
• MAC UK Neuroscience — Blackpool, United Kingdom

Full record on ClinicalTrials.gov

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