Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Neuropathy, Painful Diabetic Neuralgia Diabetic Polyneuropathy Diabetic Mononeuropathy

Keywords

diabetes mellitusdiabetic microvascular injurypainful 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

placeboDrug

twice daily for 4 weeks

002

RWJ-333369 (carisbamate)Drug

200 mg tablet twice daily for 4 weeks

001

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

SK Life Science, Inc.
Industrylead

MeSH Terms

Conditions

Diabetic NeuropathiesDiabetes Mellitus

Interventions

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

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional 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

Enrollment

132 participants (actual enrollment reported by the registry).

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 2007

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

002

001

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

002

001

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record