deltatrials
Terminated PHASE4 INTERVENTIONAL 1-arm NCT00779038

Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery

Clinical Outcome Study in Postoperative Pain Management to Demonstrate the Efficacy and Safety of IONSYS (Fentanyl ITS Iontophoretic Transdermal System) in Daily Clinical Practice and to Assess Its Convenience (IPAC)

Sponsor: Janssen Cilag N.V./S.A.

Interventions Fentanyl ITS
Updated 7 times since 2017 Last updated: Apr 22, 2014 Started: Aug 31, 2008 Primary completion: Sep 30, 2008 Completion: Sep 30, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Stopped prematurely in 2008 due to IONSYS withdrawal off the market globally

A PHASE4 clinical study on Pain, Postoperative, this trial is terminated or withdrawn. The trial is conducted by Janssen Cilag N.V./S.A. and has accumulated 7 data snapshots since 2008. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 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 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 10 months · monthly snapshotTerminated

Change History

7 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE4

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE4

  4. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE4

  5. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE4

Show 2 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE4

  2. Jan 2017 — Jun 2018 [monthly]

    Terminated PHASE4

    First recorded

Aug 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Janssen Cilag N.V./S.A.
Data source: Janssen Cilag N.V./S.A.

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