deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT04785638

An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries

An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Open Ventral Hernia Repair, Abdominoplasty, Open Abdominal Hysterectomy, Laparoscopic-assisted Colectomy, and Reduction Mammoplasty

Sponsor: Innocoll

Conditions Abdominoplasty Colectomy Hernia, Ventral Hysterectomy Pain, Postoperative Reduction Mammoplasty
Interventions INL-001 (bupivacaine hydrochloride) implant
Updated 10 times since 2021 Last updated: Feb 10, 2023 Started: Apr 14, 2021 Primary completion: Jan 10, 2023 Completion: Jan 10, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04785638, this PHASE3 trial focuses on Abdominoplasty and Colectomy and remains completed. Sponsored by Innocoll, it has been updated 10 times since 2021, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshotNot Yet Recruiting~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshotRecruiting~Sep 2021 – ~Feb 2022 · 5 months · monthly snapshotRecruiting~Feb 2022 – ~Jun 2022 · 4 months · monthly snapshotRecruiting~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshotRecruiting~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshotRecruiting~Sep 2022 – ~Mar 2023 · 6 months · monthly snapshotRecruiting~Mar 2023 – ~Jul 2024 · 16 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 23 months · monthly snapshotCompleted

Change History

10 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Mar 2023 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Recruiting → Completed

  4. Sep 2022 — Mar 2023 [monthly]

    Recruiting PHASE3

  5. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

▶ Show 5 earlier versions

  1. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  2. Feb 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  3. Sep 2021 — Feb 2022 [monthly]

    Recruiting PHASE3

  4. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  5. Apr 2021 — Jun 2021 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Innocoll
Data source: Innocoll

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

Study Locations