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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 is a Phase 1 study of Hernioplasty that has completed, run by Innocoll. The registered enrollment target is 52 participants. The trial reports 5 study locations across 4 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03234374
The ClinicalTrials.gov registry entry for NCT03234374 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 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 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 reports 5 study locations spanning 4 distinct geographic areas - top geographies include 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.
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