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NCT04785625 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty
A Phase 3 study, sponsored by Innocoll.
- Completed
- Registry status
- Phase 3
- Development phase
- 366
- Enrollment target
NCT04785625 is a Phase 3 study that has completed, run by Innocoll. The registered enrollment target is 366 participants.
The verdict
NCT04785625, a Phase 3 study, has completed, sponsored by Innocoll.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 366 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty to evaluate postoperative analgesia.
Interventions
- COMBINATION_PRODUCT Bupivacaine Hydrochloride
- COMBINATION_PRODUCT Placebo collagen-matrix implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2021-04-29 |
| Est. Completion | 2021-10-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04785625
The ClinicalTrials.gov registry entry for NCT04785625 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 366 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 2 interventions - of which Bupivacaine Hydrochloride is the first listed.
NCT04785625 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04785625 about?
NCT04785625 is a clinical study titled "Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty". This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty to evaluate postoperative analgesia.
What is the current status of trial NCT04785625?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 366 participants. The study started on 2021-04-29. Estimated completion is 2021-10-27.
What interventions are being tested in trial NCT04785625?
The interventions under investigation include: Bupivacaine Hydrochloride (COMBINATION_PRODUCT), Placebo collagen-matrix implant (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04785625?
This trial is sponsored by Innocoll, which has 19 total clinical trials registered on ClinicalTrials.gov.
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