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

NCT00501202 | Completed Phase 2

• 2 other identifiers: CR010366333369NPP2002
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

diabetes mellitus; diabetic microvascular injury; painful polyneuropathy.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

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

Study Arms (2)

002

PLACEBO COMPARATOR

placebo twice daily for 4 weeks

Drug: placebo

001

EXPERIMENTAL

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

Drug: RWJ-333369 (carisbamate)

Interventions

placebo DRUG

twice daily for 4 weeks

002

RWJ-333369 (carisbamate) DRUG

200 mg tablet twice daily for 4 weeks

001

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• SK Life Science, Inc.: lead

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus

Interventions

S-2-O-carbamoyl-1-o-chlorophenyl-ethanol

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: March 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 1, 2018

Record last verified: 2018-04