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Pharmacokinetics, Relative Bioavailability and Safety of INL-001 Compared to Marcaine After Open Hernioplasty
NCT03234374 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03234374 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Texas, Alabama, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03234374?
This trial is sponsored by Innocoll, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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