Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair
Public ClinicalTrials.gov record NCT03262688. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Analgesic Effect of the INL-001 Bupivacaine Hydrochloride (HCl) Collagen-Matrix Implant in Children 2 to <17 Years of Age Following Open Inguinal Hernia Repair
Study identification
- NCT ID
- NCT03262688
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Innocoll
- Industry
- Enrollment
- 159 participants
Conditions and interventions
Conditions
Interventions
- Bupivacaine HCl collagen-matrix implant Drug
- Bupivacaine HCl infiltration Drug
Drug
Eligibility (public fields only)
- Age range
- 2 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 15, 2017
- Primary completion
- Jan 30, 2024
- Completion
- Jan 30, 2024
- Last update posted
- Jul 29, 2021
2017 – 2024
United States locations
- U.S. sites
- 11
- U.S. states
- 5
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alliance Research Centers | Laguna Hills | California | 92653 | Recruiting |
| Cornerstone Research Institute | Altamonte Springs | Florida | 32701 | Recruiting |
| Medical Research Center | Miami | Florida | 33144 | Withdrawn |
| Elion & Volhard Pharmaceutical Research (E&V PR) | Miami | Florida | 33165 | Withdrawn |
| Children's Hospital of Pittsburgh of UPMC (CHP-UPMC) | Pittsburgh | Pennsylvania | 15224 | Recruiting |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | Recruiting |
| El Paso Children's Hospital | El Paso | Texas | 79905 | Recruiting |
| Memorial Hermann Memorial City Medical Center | Houston | Texas | 77024 | Recruiting |
| The Woman's Hospital of Texas | Houston | Texas | 77054 | Withdrawn |
| Plano Surgical Hospital | Plano | Texas | 75093 | Recruiting |
| Jean Brown Research | Salt Lake City | Utah | 84124 | Active, not recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03262688, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 29, 2021 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03262688 live on ClinicalTrials.gov.