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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: Completed Phase 3 study, sponsored by Innocoll.
NCT04785625 is a Phase 3 study that has completed, run by Innocoll. The registered enrollment target is 366 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Sum of pain intensity (SPI).The time weighted sum of pain intensity from 0 to 24hours (ie, the area under the NRS PI curve from 0 to 24 hours). For the purpose of SPI computation, Pain Intensity at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation. Minimum value would be "0" and Maximum value would be 240. Time-weighted SPI is calculated as the sum of the pain intensities between successive time points (i.e., if SPI24 = ∑\[PI x (time t - time t-1)\], where "
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 |
What the finished NCT04785625 record still lists
NCT04785625 is an interventional study that assigns participants to a tested intervention. The registered 366 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 (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Bupivacaine Hydrochloride is the first listed.
NCT04785625 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04785625's enrollment target sits among peer trials
366 999th of 2000 higher than 1,000 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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