deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT00315445

The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain. (BP96-0604)

A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain

Sponsor: Purdue Pharma LP

Conditions Back Pain
Interventions Buprenorphine transdermal patch OXY/APAP Placebo oxycodone/acetaminophen tablets Placebo transdermal patch (TDS)
Updated 7 times since 2017 Last updated: Aug 27, 2012 Started: Dec 31, 1997 Primary completion: May 31, 1998 Completion: May 31, 1998
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 Back Pain, this trial is completed. The trial is conducted by Purdue Pharma LP and has accumulated 7 data snapshots since 1997. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 20 months · monthly snapshotCompleted

Change History

7 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

▶ Show 2 earlier versions

  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Dec 1997

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