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INL-001 for Postoperative Pain After Hernia Surgery

Phase 3
Waitlist Available
Research Sponsored by Innocoll
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after time 0
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial

Summary

This trial involves children aged 2 to 17 undergoing hernia surgery. It compares a new pain relief implant with a standard injection. The goal is to find the best dose for each age group and ensure effective pain management.

Who is the study for?
This trial is for children aged 2 to <17 years needing elective open inguinal hernia repair. They must be able to follow the study's procedures and have a guardian who can consent. Girls of childbearing age need negative pregnancy tests. Kids with major surgery in the last 3 months, other clinical trials within 30 days, or significant health risks are excluded.
What is being tested?
The study is testing two pain management methods after hernia surgery: an implant containing Bupivacaine HCl and direct infiltration with Bupivacaine HCl. It starts with older kids (12-<17) and moves to younger groups to find suitable doses.
What are the potential side effects?
Possible side effects include reactions at the implant site, sensitivity issues due to amide local anesthetics or bovine products in the implant, and typical bupivacaine-related effects like nerve damage symptoms or heart problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after time 0
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after time 0 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
12-lead ECG
3-lead ECG
Adverse events
+9 more
Secondary study objectives
AUC0-last
AUC0-∞
Cmax
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: INL-001Experimental Treatment1 Intervention
Bupivacaine HCl collagen-matrix implant
Group II: InfiltrationActive Control1 Intervention
Bupivacaine HCl infiltration

Find a Location

Who is running the clinical trial?

InnocollLead Sponsor
20 Previous Clinical Trials
4,831 Total Patients Enrolled
Premier Research Group plcIndustry Sponsor
63 Previous Clinical Trials
73,749 Total Patients Enrolled
Gwendolyn Niebler, DOStudy DirectorInnocoll

Media Library

Bupivacaine HCl collagen-matrix implant Clinical Trial Eligibility Overview. Trial Name: NCT03262688 — Phase 3
Inguinal Hernia Research Study Groups: INL-001, Infiltration
Inguinal Hernia Clinical Trial 2023: Bupivacaine HCl collagen-matrix implant Highlights & Side Effects. Trial Name: NCT03262688 — Phase 3
Bupivacaine HCl collagen-matrix implant 2023 Treatment Timeline for Medical Study. Trial Name: NCT03262688 — Phase 3
~19 spots leftby Dec 2025
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