Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty

Phase 3

Completed

• Conditions: Pain, Postoperative; Abdominoplasty
• Interventions: Combination Product: Bupivacaine Hydrochloride; Combination Product: Placebo collagen-matrix implant

• Registration Number: NCT04785625
• Lead Sponsor: Innocoll

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty to evaluate postoperative analgesia.

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty. Patients will undergo abdominoplasty and have INL-001 or placebo implanted intraoperatively.

The study includes a screening period, an inpatient period (preoperative, intraoperative, immediately postoperative) of approximately 4 days and an outpatient follow-up period (up to 30 days after treatment). Efficacy assessments will be made through 72 hours after treatment (after implant placement). Posttreatment safety assessments will be made throughout the study after the informed consent form is signed, and as specifically scheduled through 72 hours posttreatment, on day 7 (telephone), on day 15 (clinic visit), and on day 30 (clinic visit). Unless the investigator determines further hospitalization is necessary, the patient will be discharged on the day occurring 72 hours after surgery Inpatient day 4).

During the screening period, all patients will undergo eligibility and other screening and safety assessments. On the day of surgery, patient eligibility will be reconfirmed before the start of surgery, patients will be randomly assigned to treatment, and adverse events and prior/concomitant medications will be reviewed. Patients will undergo an abdominoplasty conducted under general anesthesia.

Adverse event and concomitant medication information, including use of rescue pain medication, will be collected throughout the study (inpatient and outpatient). Surgical wound healing/grading assessments and assessment for signs and symptoms potentially indicative of systemic bupivacaine toxicity will be made.

After surgery, patient reports of pain intensity using an 11-point numeric pain rating scale (NPRS) will be recorded at multiple time points through 72 hours posttreatment. Patients will be permitted rescue medication (oral and/or intravenous) to manage breakthrough pain when it occurs.

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-08
• Study Start: 2021-04-29
• Primary Completion: 2021-10-27
• Study Completion: 2021-10-27
• Disposition First Submitted: 2022-10-13
• Disposition First Submitted QC: 2022-10-26
• Disposition First Posted: 2022-10-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INL-001 (bupivacaine hydrochloride) implant	Bupivacaine Hydrochloride	INL-001 (bupivacaine hydrochloride) implant
Placebo implant	Placebo collagen-matrix implant	Placebo collagen-matrix implant

Primary Outcome Measures

Name	Time	Method
SPI24	0 to 24 hours	Sum of pain intensity (SPI).The time weighted sum of pain intensity from 0 to 24hours (ie, the area under the NRS PI curve from 0 to 24 hours). For the purpose of SPI computation, Pain Intensity at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation. Minimum value would be "0" and Maximum value would be 240. Time-weighted SPI is calculated as the sum of the pain intensities between successive time points (i.e., if SPI24 = ∑\[PI x (time t - time t-1)\], where "t" represents a given time point,"t-1" represents the previous time point, and time is expressed in hours). This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule.

Secondary Outcome Measures

Name	Time	Method
The secondary objective is to assess the safety and tolerability of INL 001 implants after placement	Day 1 through Day 30	Safety is assessed and measured by frequency and severity of adverse events

Trial Locations

Locations (4)

Lotus Clinical Research; 🇺🇸 Pasadena, California, United States

HD Research; 🇺🇸 Bellaire, Texas, United States

Midwest Clinical Research; 🇺🇸 Dayton, Ohio, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States