Study for Safety and Effectiveness of RWJ-333369 (Carsibamate) for the Treatment of Diabetic Peri… (NCT00501202) | Clinical Trial Compass
CompletedPhase 2
Study for Safety and Effectiveness of RWJ-333369 (Carsibamate) for the Treatment of Diabetic Peripheral Neuropathy (DPN).
132 participantsStarted 2007-03
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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 ap…
What they're measuring
1
The mean of the last 7 average daily DPN scores of the first treatment period on days when study drug is taken.