Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

April 30, 2008

Study Completion Date

May 31, 2008

Conditions
Low Back Pain
Interventions
DRUG

tapentadol (CG5503) Immediate Release IR

21 day Open Label: an adjustable dose of Tapentadol IR 50-100mg orally every 4-6 hours to maximum total daily dose (TDD) dose of 500 mg during open label period

DRUG

tapentadol (CG5503) Extended Release (ER)

During 2 double blind periods: Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in the first intervention period of double-blind phase and Tapentadol IR in the second or Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second

DRUG

tapentadol (CG5503) Immediate Release (IR)

Following open label period is 2 double blind periods: Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in second or Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Grünenthal GmbH

INDUSTRY

lead

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

INDUSTRY