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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501202
Recruitment Status : Completed
First Posted : July 16, 2007
Last Update Posted : May 1, 2018
Information provided by (Responsible Party):
SK Life Science, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. The mean of the last 7 average daily DPN scores of the first treatment period on days when study drug is taken. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 4 weeks (2 four-week treatment periods (crossover design) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00501202

Sponsors and Collaborators
SK Life Science, Inc.
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Responsible Party: SK Life Science, Inc. Identifier: NCT00501202    
Other Study ID Numbers: CR010366
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Keywords provided by SK Life Science, Inc.:
diabetes mellitus
diabetic microvascular injury
painful polyneuropathy.
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Diabetes Complications