CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 117 enrolled
Drug / intervention
tapentadol (CG5503) Immediate Release IR +2 moredrug
Likely dose
Tapentadol IR 50-100 mg orally every 4-6 hours (open-label phase); Tapentadol ER 100, 150, 200, or 250 mg twice daily (double-blind phase)AI-extracted
Key inclusion· 5
  • ✓Low back pain of non-malignant origin present for at least 3 months immediately before study entry
  • ✓On drug treatment for pain for at least 3 months before screening and dissatisfied with current therapy
  • ✓If receiving opioids, maximum 160 mg/day of oral morphine equivalent
  • ✓Baseline pain score ≥5 on 11-point numeric rating scale (NRS) during last 3 days of washout for open-label entry
Key exclusion· 12
  • ✕Conditions other than low back pain that could make pain assessment difficult
  • ✕Low back surgery within 3 months of screening or planned during study
  • ✕Planned surgery or painful procedure during the study
  • ✕Clinically significant disease that may affect efficacy or safety assessments

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00594516
NCT00594516Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, 2-Period, Crossover Study to Establish the Dose Equivalence and Direct Conversion Between Immediate Release (IR) and Extended-Release (ER) CG5503 in Subjects With Moderate-to-Severe, Chronic Low Back Pain

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Jan 15, 2008·Updated Apr 15, 2015

In Brief

A Phase 3 clinical trial evaluating tapentadol (CG5503) Immediate Release IR, tapentadol (CG5503) Extended Release (ER), and 1 other intervention for Low Back Pain. Completed, enrolled 117 participants.

Detailed Summary

The objective of this study is to test the idea that the immediate-release (IR) form of tapentadol (CG5503) can be directly converted into an approximately equivalent total daily dose (TDD) of the extended-release (ER) form, and vice-versa, with equivalent safety and efficacy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
Countries--
CollaboratorsGrünenthal GmbH

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 15, 2008
Enrollment StartDec 1, 2007
Primary CompletionApr 1, 2008
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.5 years ago

Interventions

tapentadol (CG5503) Immediate Release IRdrug

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

tapentadol (CG5503) Extended Release (ER)drug

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

tapentadol (CG5503) Immediate Release (IR)drug

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