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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
Has a body mass index of 18-35 kg/m2.
Has a planned (nonemergency) open ventral hernia repair, abdominoplasty (with rectus sheath plication, in the opinion of the surgeon), open abdominal hysterectomy, laparoscopic-assisted colectomy, or reduction mammoplasty to be conducted using standard surgical technique under general anesthesia.
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
Pivotal Trial
No Placebo-Only Group

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after the intervention/procedure/surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the intervention/procedure/surgery 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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I sign up for the clinical trial?

"Eligibility criteria for this clinical trial includes being over 18 years old, having had a hysterectomy, and being below 75 years of age. Up to 100 individuals will be enrolled in the study."

Answered by AI

Does this experiment have an age limit for participants?

"According to the inclusion criteria specified by the study, patients aged 18 to 75 are qualified applicants. Out of the 668 trials for people over 65 and 107 trials for those under 18, this is one of many medical studies."

Answered by AI

Are new patients being taken in for this clinical trial?

"Yes, this information can be found on clinicaltrials.gov. The posting date was April 14th, 2021 and the most recent edit occurred on August 29th, 2022."

Answered by AI

Are there any adverse effects to the INL-001 (bupivacaine hydrochloride) implant procedure?

"INL-001 (bupivacaine hydrochloride) implant is rated 3 out of 3 in terms of safety by our Power team. This Phase 3 trial status means that not only does this product have some data supporting efficacy, but also multiple rounds of data affirming its safety."

Answered by AI

How many patients are included in this clinical trial?

"To carry out this research, 100 participants that meet the required inclusion criteria are needed. Innocoll, the sponsor of this trial, will be administering the study from locations such as Endeavor Clinical Trials in San Antonio and Baylor College of Medicine in Florence."

Answered by AI

Are there different areas where this experiment is being conducted?

"8 clinical trial sites are currently recruiting patients for this study. If you choose to participate in the study, please select the site nearest to your location from the list below to minimize travel requirements.San AntonioFlorence Dayton 8 other locations"

Answered by AI

What type of pain does INL-001 (bupivacaine hydrochloride) help to alleviate?

"The INL-001 (bupivacaine hydrochloride) implant is most often used to treat permphigus. However, it has also been effective in treating acute nonspecific tenosynovitis, lupus erythematosus cell, and general anesthesia."

Answered by AI

What other research has been conducted using INL-001 (bupivacaine hydrochloride) implant?

"The INL-001 (bupivacaine hydrochloride) implant was first used in 2009 at Chang Gung Memorial Hospital. Since then, it has been employed in 728 completed studies with 124 of those trials still active. A considerable number of these active studies are based out of San Antonio, Alabama."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
British Columbia
How old are they?
18 - 65
What site did they apply to?
Lotus Clinical Research
Helen Keller Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~26 spots leftby Feb 2025