Study for Safety and Effectiveness of RWJ-333369 (Carsibamate) for the Treatment of Diabetic Peripheral Neuropathy (DPN).

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200 mg of RWJ-333369 given twice daily by mouth compared with placebo in the treatment of Diabetic Peripheral Neuropathy (DPN).

Detailed Description
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Diabetes mellitus is the most common cause of neuropathy in the Western World, with up to 50% of patients developing neuropathy as a long-term complication of the illness, of whom 10% experience pain. Diabetic neuropathy most often affects the lower extremities and may be severe if inadequately treated. Blood glucose control is a critical treatment element, and several medications have been demonstrated to be effective in treating Diabetic Peripheral Neuropathy (DPN), including antiepileptic drugs, antidepressants and opioid analgesics. These medications are often limited by incomplete pain relief and side effects. This is a randomized (study medication is assigned by chance), double-blind (neither the Investigator or the patient know the name of the assigned study medication), placebo-controlled, crossover, parallel-group, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4 weeks will be more effective than placebo in reducing pain due to DPN, as measured by average daily DPN pain scores. Patients will receive 200 mg of RWJ-333369 or matching placebo tablets, given in equally divided doses twice daily by mouth with or without food, for 4 weeks in each of the 2 treatment periods.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of RWJ 333369 for the Treatment of Neuropathic Pain in Diabetic Peripheral Neuropathy.

Conditions
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Diabetic Neuropathy, Painful, Diabetic Neuralgia, Diabetic Polyneuropathy, Diabetic Mononeuropathy

Intervention / Treatment
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* Drug: placebo
* Drug: RWJ-333369 (carisbamate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have diabetes mellitus (Type 1 or 2) for longer than 1 year Have clinical evidence of diabetic peripheral neuropathy in the lower extremities for 1 to 5 years before study entry Experienced lower extremity pain due to diabetic peripheral neuropathy on nearly a daily basis for the previous 3 months Have hemoglobin A1c levels less than or equal to 10% Have a stable diabetic treatment regimen, including oral medications for controlling diabetes, insulin, or diet for 3 months before screening Women must be postmenopausal for at least 2 years, sexually abstinent, or if sexually active, be practicing an effective method of birth control, and have a negative serum pregnancy test at screening. Exclusion Criteria: History of a poor response to 3 or more medications for diabetic peripheral neuropathy (DPN), with poor response is defined as treatment with medications in the following categories of therapy for at least 1 month at therapeutic dosages without at least moderate improvement, as judged by the study doctor: antiepileptic drugs, tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors (SNRIs), opioid analgesics, or lidocaine patch currently taking tricyclic antidepressants, Coumadin (warfarin), or continued treatment with an antiepileptic drug for any indication, Note: If taking these medications, to be eligible for the study, they must be tapered and discontinued Prior neurolytic treatment (destruction of nerves by the application of chemicals, heat, or cold), intrathecal pumps, or spinal cord stimulators for DPN pain Use of herbal creams or ointments for pain relief within 48 hours, capsaicin within 6 months, or systemic corticosteroids within 3 months before the baseline period Prior exposure to RWJ-333369 (carisbamate).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 002<br>placebo twice daily for 4 weeks | Drug: placebo<br>* twice daily for 4 weeks<br>|
| Experimental: 001<br>RWJ-333369 (carisbamate) 200 mg tablet twice daily for 4 weeks | Drug: RWJ-333369 (carisbamate)<br>* 200 mg tablet twice daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean of the last 7 average daily DPN scores of the first treatment period on days when study drug is taken. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The means of the last 7 average daily DPN pain scores with no use of rescue medication, the last 7 current daily DPN pain scores, the last 7 maximum daily DPN pain scores, and the last 7 daily sleep interference scores. |  | 4 weeks (2 four-week treatment periods (crossover design) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, diabetic microvascular injury, painful polyneuropathy.