Completed PHASE3 INTERVENTIONAL 2-arm NCT00986180

NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain

A Randomized, Double-Blind, Parallel-Group Study of NUCYNTA (Tapentadol) Immediate Release vs. Oxycodone Immediate Release for the Treatment of Acute Low Back Pain

Sponsor: Grünenthal GmbH

Conditions Back Pain Back Pain With Radiation Low Back Pain Pain

Interventions NUCYNTA Oxycodone IR

Updated 8 times since 2017 Last updated: Dec 17, 2012 Started: Sep 30, 2009 Primary completion: Dec 31, 2010 Completion: Dec 31, 2010

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

Listed as NCT00986180, this PHASE3 trial focuses on Back Pain and Back Pain With Radiation and remains completed. Sponsored by Grünenthal GmbH, it has been updated 8 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Dec 2021 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Dec 2021 [monthly]

Completed PHASE3

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Sep 2009

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Grünenthal GmbH
Ortho-McNeil Janssen Scientific Affairs, LLC

Data source: Ortho-McNeil Janssen Scientific Affairs, LLC

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

Study Locations

Akron, United States , Altoona, United States , Andover, United States , Atco, United States , Atlanta, United States , Austin, United States , Avon, United States , Beavercreek, United States , Blackwood, United States , Boynton Beach, United States and 64 more locations