- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00501202
Study for Safety and Effectiveness of RWJ-333369 (Carsibamate) for the Treatment of Diabetic Peripheral Neuropathy (DPN).
April 27, 2018 updated by: SK Life Science, Inc.
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of RWJ 333369 for the Treatment of Neuropathic Pain in Diabetic Peripheral Neuropathy.
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
132
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 002
placebo twice daily for 4 weeks
|
twice daily for 4 weeks
|
Experimental: 001
RWJ-333369 (carisbamate) 200 mg tablet twice daily for 4 weeks
|
200 mg tablet twice daily for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
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.
Time Frame: 4 weeks (2 four-week treatment periods (crossover design)
|
4 weeks (2 four-week treatment periods (crossover design)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
July 12, 2007
First Submitted That Met QC Criteria
July 12, 2007
First Posted (Estimate)
July 16, 2007
Study Record Updates
Last Update Posted (Actual)
May 1, 2018
Last Update Submitted That Met QC Criteria
April 27, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR010366
- 333369NPP2002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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