deltatrials
Terminated PHASE4 NCT00210561

A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) for the Treatment of Acute Low Back Pain

Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Updated 9 times since 2017 Last updated: Jun 8, 2011 Started: Mar 31, 2005 Completion: Apr 30, 2005

This PHASE4 trial investigates Back Pain and Low Back Pain and is currently terminated or withdrawn. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. leads this study, which shows 9 recorded versions since 2005 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshotTerminated~Aug 2017 – ~May 2018 · 9 months · monthly snapshotTerminated~May 2018 – ~Jun 2018 · 31 days · monthly snapshotTerminated~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotTerminated~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated

Change History

9 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE4

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE4

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE4

  5. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE4

Show 4 earlier versions
  1. Jun 2018 — Nov 2020 [monthly]

    Terminated PHASE4

  2. May 2018 — Jun 2018 [monthly]

    Terminated PHASE4

  3. Aug 2017 — May 2018 [monthly]

    Terminated PHASE4

  4. Jan 2017 — Aug 2017 [monthly]

    Terminated PHASE4

    First recorded

Mar 2005

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  • PriCara, Unit of Ortho-McNeil, Inc.
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.