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INL-001 (bupivacaine hydrochloride) implant for Postoperative Pain

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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours
Awards & highlights

Study Summary

This trial looks at the safety and how well the body tolerates a new pain medication given as an implant following various types of surgery.

Eligible Conditions
  • Postoperative Pain
  • Ventral Hernia
  • Tummy Tuck
  • Hysterectomy
  • Colectomy
  • Breast Reduction Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the safety and tolerability
Secondary outcome measures
AUC
AUC0-∞
Cmax
+4 more
Other outcome measures
15-item Quality of Recovery (QoR-15) Questionnaire
Opioid-related Symptom Distress Scale (OR-SDS)
Patient Global Assessment (PGA) as Related to Postoperative Pain
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: INL-001 (bupivacaine hydrochloride) implantExperimental Treatment1 Intervention
INL-001 (bupivacaine hydrochloride) implant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INL-001 (bupivacaine hydrochloride) implant
2021
Completed Phase 3
~100

Find a Location

Who is running the clinical trial?

InnocollLead Sponsor
20 Previous Clinical Trials
4,890 Total Patients Enrolled
5 Trials studying Postoperative Pain
326 Patients Enrolled for Postoperative Pain
Anne ArriagaStudy DirectorLotus Clinical Research
1 Previous Clinical Trials
366 Total Patients Enrolled
~24 spots leftby May 2025
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