Completed PHASE3 INTERVENTIONAL 3-arm NCT00449176

A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain

A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Subjects With Moderate to Severe Chronic Low Back Pain

Sponsor: Grünenthal GmbH

Conditions Low Back Pain

Interventions oxycodone CR placebo tapentadol (CG5503) ER

Updated 6 times since 2017 Last updated: Apr 26, 2012 Started: Feb 28, 2007 Primary completion: May 31, 2008 Completion: May 31, 2008

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Low Back Pain, this trial is completed. The trial is conducted by Grünenthal GmbH and has accumulated 6 data snapshots since 2007. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Feb 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

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

Data source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.