A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)

PHASE3TerminatedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

April 30, 2010

Study Completion Date

June 30, 2010

Conditions
Diabetic Neuropathy, PainfulDiabetic Polyneuropathy
Interventions
DRUG

Tapentadol extended release (ER)

100, 150, 200, 250 mg twice daily for 52 weeks

DRUG

Oxycodone controlled release (CR)

20, 30, 40, 50 mg twice daily for 52 weeks

Trial Locations (23)

Unknown

Mesa

Tucson

Fruitland Park

New Port Richey

Oviedo

Tampa

Libertyville

Franklin

Paducah

Wellesley Hills

Albuquerque

New York

Greenville

Hickory

Wilmington

Winston-Salem

Kettering

Tulsa

Greer

Dallas

Odessa

San Antonio

Virginia Beach

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Grünenthal GmbH

INDUSTRY

lead

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

INDUSTRY