Back to results

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

Primary Purpose

Diabetic Neuropathy, Painful, Diabetic Neuralgia, Diabetic Polyneuropathy

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

placebo

RWJ-333369 (carisbamate)

About this trial

This is an interventional treatment trial for Diabetic Neuropathy, Painful focused on measuring diabetes mellitus, diabetic microvascular injury, painful polyneuropathy.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

002

001

Arm Description

placebo twice daily for 4 weeks

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

Outcomes

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.

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.

Full Information

NCT ID

NCT00501202

First Posted

July 12, 2007

Last Updated

April 27, 2018

Sponsor

SK Life Science, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00501202

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SK Life Science, Inc.

4. Oversight

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

diabetes mellitus, diabetic microvascular injury, painful polyneuropathy.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

132 (Actual)

8. Arms, Groups, and Interventions

Arm Title

002

Arm Type

Placebo Comparator

Arm Description

placebo twice daily for 4 weeks

Arm Title

001

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

twice daily for 4 weeks

Intervention Type

Drug

Intervention Name(s)

RWJ-333369 (carisbamate)

Intervention Description

200 mg tablet twice daily for 4 weeks

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Time Frame

4 weeks (2 four-week treatment periods (crossover design)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Organizational Affiliation

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs