Study Summary
This trial is looking at what is the best dose of a new pain medicine for children who are getting surgery to fix an inguinal hernia.
- Postoperative Pain
- Inguinal Hernia
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
12 Primary · 6 Secondary · Reporting Duration: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Infiltration
1 of 2
INL-001
1 of 2
Active Control
Experimental Treatment
159 Total Participants · 2 Treatment Groups
Primary Treatment: Bupivacaine HCl collagen-matrix implant · No Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 2 - 16 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Frequently Asked Questions
What primary goals does this research project hope to accomplish?
"According to the study sponsor, Innocoll, the primary outcome measure for this trial will be oxygen saturation levels over a period of three days. Secondary outcomes include Tmax (time to maximum observed plasma concentration), AUC0-∞ (area under the plasma concentration time curve from time zero to extrapolated infinity), and pain intensity as assessed using an 11-point NRS scale (for children 12 to <17 years of age), FACES pain severity scale (children 4 through <12 years of age), or FLACC (children 2 and 3 years of age) immediately before receiving any rescue medication for breakthrough pain." - Anonymous Online Contributor
Is this study enrolling new participants at the moment?
"Indeed, the clinical trial is recruiting patients as stated on clinicaltrials.gov. The study was posted June 16th, 2017 and updated July 23rd, 2021. They are looking for 159 individuals to participate at 7 different locations." - Anonymous Online Contributor
Are there any other precedents for a Bupivacaine HCl collagen-matrix implant?
"There are 124 clinical trials that have bupivacaine hydrochloride collagen-matrix implants as their focus. Of these, 21 are in the third and final stage. The majority of these studies are based out of Philadelphia, Pennsylvania; however, there are a total of 169 locations running these sorts of trials." - Anonymous Online Contributor
Might I be eligible to enroll in this clinical trial?
"This study is looking for 159 people, within the ages of 2 and 16 who currently have postoperative pain. It is required that patients also meet the following criteria: Be willing and able to cooperate with all the requirements of the study., Be willing to sign an assent (if appropriate dependent upon the child's age, understanding, and IRB requirements), before the conduct of any study procedure., Be a male or female 2 to <17 years of age., Be premenarche or have a serum confirmed negative pregnancy test at screening and a negative urine pregnancy test before surgery on day 1, if an adolescent female of childbearing" - Anonymous Online Contributor
Does the age limit for this research project preclude elderly participation?
"Children aged 2 to 16 can enroll in this clinical trial. Out of the 54 trials available for minors, this is one option. For patients 65 years and older, there are 363 different trials from which they may choose." - Anonymous Online Contributor
For what condition is Bupivacaine HCl collagen-matrix implant commonly prescribed?
"The conditions of permphigus, acute nonspecific tenosynovitis, and general anesthesia can all be remedied by Bupivacaine HCl collagen-matrix implant." - Anonymous Online Contributor
How many volunteers are being sought for this clinical trial?
"A total of 159 participants who meet the eligibility requirements are required for this clinical trial. Patients can enroll at sites such as El Paso Children's Hospital in El Paso, Pennsylvania and Children's Hospital of Pittsburgh of UPMC (CHP-UPMC) in Pittsburgh, California." - Anonymous Online Contributor
Has the Bupivacaine HCl collagen-matrix implant received FDA approval?
"There is both efficacy and safety data available for Bupivacaine HCl collagen-matrix implant, thus it received a score of 3." - Anonymous Online Contributor