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NCT03234374 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Relative Bioavailability and Safety of INL-001 Compared to Marcaine After Open Hernioplasty
A Phase 1 study of Hernioplasty, sponsored by Innocoll.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 5
- Study locations
NCT03234374: Completed Phase 1 study of Hernioplasty, sponsored by Innocoll.
NCT03234374 is a Phase 1 study of Hernioplasty that has completed, run by Innocoll. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03234374, a Phase 1 study of Hernioplasty, has completed, sponsored by Innocoll.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a multicenter randomized, single-blind, controlled study. The primary objectives of this study are to obtain the pharmacokinetic profile and the relative bioavailability of the INL-001 matrix during and after open hernioplasty compared to Marcaine™ 0.25% infiltration.
Primary Outcome
Maximum (peak) plasma concentration
Conditions Studied
Interventions
- COMBINATION_PRODUCT INL-001 (bupivacaine HCl collagen implant)
- DRUG Marcaine 0.25% infiltration
Study Locations (5)
Texas
- Research Concepts - Houston
- Research Concepts GP, LLC - Houston - Houston
Alabama
- Pinnacle Research Group - Anniston
Florida
- Park Place Surgery Center - Longwood
Utah
- Jean Brown Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2017-06-02 |
| Est. Completion | 2017-08-15 |
| Phase | Phase 1 |
What the finished NCT03234374 record still lists
NCT03234374 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 1 condition, with Hernioplasty appearing as the primary indexed condition, and to 2 interventions - of which INL-001 (bupivacaine HCl collagen implant) is the first listed.
NCT03234374 lists 5 locations in 4 states (Texas, Alabama, Florida).
Frequently Asked Questions
What is clinical trial NCT03234374 about?
NCT03234374 is a clinical study titled "Pharmacokinetics, Relative Bioavailability and Safety of INL-001 Compared to Marcaine After Open Hernioplasty". This is a multicenter randomized, single-blind, controlled study. The primary objectives of this study are to obtain the pharmacokinetic profile and the relative bioavailability of the INL-001 matrix during and after open hernioplasty compared to Marcaine™ 0.25% infiltration.
What is the current status of trial NCT03234374?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2017-06-02. Estimated completion is 2017-08-15.
What conditions does trial NCT03234374 study?
This clinical trial studies the following conditions: Hernioplasty.
What interventions are being tested in trial NCT03234374?
The interventions under investigation include: INL-001 (bupivacaine HCl collagen implant) (COMBINATION_PRODUCT), Marcaine 0.25% infiltration (DRUG).
Who is sponsoring clinical trial NCT03234374?
This trial is sponsored by Innocoll, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03234374 being conducted?
This trial has 5 study locations across Alabama, Florida, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03234374's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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