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

Sponsor

SK Life Science, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00501202

Collaborator

(none)

132

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuropathy, Painful Diabetic Neuralgia Diabetic Polyneuropathy Diabetic Mononeuropathy	Drug: placebo Drug: RWJ-333369 (carisbamate)	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 002 placebo twice daily for 4 weeks	Drug: placebo twice daily for 4 weeks
Experimental: 001 RWJ-333369 (carisbamate) 200 mg tablet twice daily for 4 weeks	Drug: RWJ-333369 (carisbamate) 200 mg tablet twice daily for 4 weeks

Arm

Intervention/Treatment

Placebo Comparator: 002

placebo twice daily for 4 weeks

Drug: placebo

twice daily for 4 weeks

Experimental: 001

RWJ-333369 (carisbamate) 200 mg tablet twice daily for 4 weeks

Drug: RWJ-333369 (carisbamate)

200 mg tablet twice daily for 4 weeks

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

SK Life Science, Inc.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.