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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 is a Phase 3 study that has completed, run by Innocoll. The registered enrollment target is 100 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04785638
The ClinicalTrials.gov registry entry for NCT04785638 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Innocoll, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which INL-001 (bupivacaine hydrochloride) implant is the first listed.
NCT04785638 reports 0 study locations.
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.
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