NCT04785625

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

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a 300-mg Dose of the INL-001 (Bupivacaine Hydrochloride) Implant in Patients Undergoing Abdominoplasty

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Innocoll · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative
• Abdominoplasty

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Bupivacaine Hydrochloride	INL-001 (bupivacaine hydrochloride) implant
COMBINATION_PRODUCT	Placebo collagen-matrix implant	Placebo collagen-matrix implant

Timeline

• Start date: 2021-04-29
• Primary completion: 2021-10-27
• Completion: 2021-10-27
• First posted: 2021-03-08
• Last updated: 2022-11-21

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study