Completed PHASE3 INTERVENTIONAL 2-arm NCT01452529

Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain

A Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open-label Run-in to Assess the Efficacy and Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Low Back Pain

Sponsor: Purdue Pharma LP

Conditions Chronic Low Back Pain

Interventions Hydrocodone bitartrate q24h film-coated tablets Placebo to match hydrocodone bitartrate q24h tablets

Updated 10 times since 2017 Last updated: Mar 2, 2020 Started: Oct 31, 2011 Primary completion: Sep 30, 2013 Completion: Oct 31, 2013

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 Chronic Low Back Pain, this trial is completed. The trial is conducted by Purdue Pharma LP and has accumulated 10 data snapshots since 2011. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

10 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Apr 2020 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 5 earlier versions

Jul 2018 — Apr 2020 [monthly]

Completed PHASE3
Jun 2018 — Jul 2018 [monthly]

Completed PHASE3
Nov 2017 — Jun 2018 [monthly]

Completed PHASE3
Feb 2017 — Nov 2017 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Oct 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Purdue Pharma LP

Data source: Purdue Pharma LP

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

Study Locations

Akron, United States , Albuquerque, United States , Altoona, United States , Anaheim, United States , Anderson, United States , Austin, United States , Bellevue, United States , Berlin, United States , Bingham Farms, United States , Birmingham, United States and 76 more locations