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NCT04785638 · ClinicalTrials.gov registry record · Phase 3
An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries
A Phase 3 study, sponsored by Innocoll.
- Completed
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT04785638: Completed Phase 3 study, sponsored by Innocoll.
NCT04785638 is a Phase 3 study that has completed, run by Innocoll. The registered enrollment target is 100 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04785638, a Phase 3 study, has completed, sponsored by Innocoll.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty.
Primary Outcome
The primary objective of the study is to evaluate the safety and tolerability of the INL-001 implant in patients. Measured by frequency and incidents of adverse events.
Interventions
- COMBINATION_PRODUCT INL-001 (bupivacaine hydrochloride) implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-04-14 |
| Est. Completion | 2023-01-10 |
| Phase | Phase 3 |
What the finished NCT04785638 record still lists
NCT04785638 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which INL-001 (bupivacaine hydrochloride) implant is the first listed.
NCT04785638 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04785638 about?
NCT04785638 is a clinical study titled "An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries". This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparosc...
What is the current status of trial NCT04785638?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2021-04-14. Estimated completion is 2023-01-10.
What interventions are being tested in trial NCT04785638?
The interventions under investigation include: INL-001 (bupivacaine hydrochloride) implant (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04785638?
This trial is sponsored by Innocoll, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04785638's enrollment target sits among peer trials
100 1681st of 2000 higher than 288 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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