A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy

PHASE3CompletedINTERVENTIONAL
Enrollment

460

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Diabetic Peripheral Neuropathy
Interventions
DRUG

Tapentadol extended release (ER)

Type= range, unit= mg, number= 100 to 250, form= tablet, route= oral use. Tapentadol ER optimal dose ranging between 100 mg and 250 mg twice daily for 15 weeks.

DRUG

Placebo

Form= tablet, route= oral use. Matching placebo twice daily.

Trial Locations (72)

Unknown

Mobile

Chandler

Mesa

Phoenix

Fresno

Orange

Redding

Sacramento

San Francisco

Spring Valley

Walnut Creek

Denver

Clearwater

Hallandale

Miami

Ormond Beach

St. Petersburg

Tampa

West Palm Beach

Atlanta

Marietta

Boise

Eagle

Meridian

Avon

Evansville

Fishers

Prairie Village

Shreveport

Owings Mills

Pasadena

Rockville

Brockton

Edina

St Louis

Cedarhurst

Flushing

New York

Rochester

Valley Stream

Williamsville

Hickory

Akron

Cincinnati

Medford

Allentown

Altoona

Duncansville

Anderson

Greer

Bulverde

Dallas

Houston

Odessa

San Antonio

Schertz

Salt Lake City

Alexandria

Norfolk

Virginia Beach

Calgary

Kelowna

Barrie

Greater Sudbury

Hamilton

Hawkesbury

Sarnia

Toronto

Dollard-des-Ormeaux

Laval

Montreal

San Juan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Grünenthal GmbH

INDUSTRY

lead

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

INDUSTRY