Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty

NCT02523599 | Completed Phase 3 Results

• 1 other identifier: INN-CB-014
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 23

Brief Summary

This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled efficacy and safety study of postoperative pain in adults who are scheduled for unilateral inguinal hernioplasty via open laparotomy (tension-free technique). Patients will assess their postoperative pain intensity (PI) using an 11-point numerical rating scale (NRS) from 0 hour through 72 hours postoperatively. The expected maximum study duration for each patient will be up to 60 days, including a maximum 30-day screening period, the day of surgery and implantation, and a 30-day post implantation period including treatment and follow-up.

Conditions

Pain, Postoperative

Keywords

post operative pain; hernioplasty; bupivacaine

Outcome Measures

Primary Outcomes (1)

• SPI24

  Sum of Pain Intensity (SPI24). The time weighted sum of pain intensity from 0 to 24 hours (ie, the area under the NRS PI curve from 0 to 24 hours). Where 0 indicated "no pain" and 10 indicated "worst pain possible". This type of measurement scale is called "NRS" or Numerical Rating Scale For the purpose of (SPI) computation, PI at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation. SPI will not be calculated for randomized but not treated patients. A lower score is a better outcome. 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.

  0 to 24 hours

Secondary Outcomes (5)

• TOpA24

  Time 0 through 24 hours

• TOpA48

  Time 0 through 48 hours

• TOpA72

  Time 0 through 72 hours

• SPI48

  0 to 48 hours

• SPI72

  0 to 72 hours

Study Arms (2)

XaraColl

EXPERIMENTAL

3 XaraColl Bupivacaine Implants each containing 100 mg of bupivacaine hydrochloride, for a 300 mg total dose

Drug: XaraColl

Placebo

PLACEBO COMPARATOR

3 placebo implants

Other: Placebo

Interventions

XaraColl DRUG

Surgical implantation of 3 bupivacaine collagen implants

Also known as: Bupivacaine collagen implant

XaraColl

Placebo OTHER

Plain collagen implant (vehicle)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a planned (non-emergent) unilateral inguinal hernioplasty (open laparotomy, tension-free technique) to be performed according to standard surgical technique under general anesthesia. Repair of multiple hernias through a single incision is permitted provided only a single mesh will be used.
• If female, is nonpregnant and nonlactating.
• If female, is either not of childbearing potential (defined as postmenopausal for ≥ 1 year or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy or hysterectomy\]) or practicing 1 of the protocol specified medically-acceptable methods of birth control and agrees to continue with the regimen throughout the duration of the study:
• Has the ability and willingness to comply with the study procedures and use of the eDiary.
• Is willing to use only permitted medications throughout the study.
• Is willing to use opioid analgesia.
• Must be able to fluently speak and understand either English or Spanish and be able to provide meaningful written informed consent for the study.

You may not qualify if:

• Has a known hypersensitivity to amide local anesthetics, morphine, acetaminophen or bovine products.
• Is scheduled for bilateral inguinal hernioplasty or other significant concurrent surgical procedures per investigator discretion.
• Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to undergo another laparotomy procedure within 30 days postoperatively.
• Has used any analgesic other than acetaminophen within 24 hours of surgery. Acetaminophen may be used on the day of surgery but is subject to preoperative restrictions for oral intake.
• Has used aspirin or aspirin-containing products within 7 days of surgery. Aspirin at a dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the patient has been on a stable dose regimen for ≥ 30 days before Screening.
• Has used systemic steroids, anticonvulsants, antiepileptics, antidepressants for the management of chronic pain, or monoamine oxidase inhibitors on a regular basis within 10 days of surgery.
• Has used any opioid analgesic for an extended daily basis (30 - 60 mg oral morphine equivalent per day for 3 or more days a week) within 4 weeks before surgery. Patients who, in the investigator's opinion, may be developing opioid tolerance are also excluded.
• Has any chronic painful condition (eg, fibromyalgia) or routinely uses pain medication other than acetaminophen (including nonsteroidal anti-inflammatory drugs \[NSAIDs\]) that, in the opinion of the investigator, may confound the assessment of pain associated with the hernioplasty.
• Has a physical or mental condition that, in the opinion of the investigator, may confound the assessment of postoperative pain after hernioplasty.
• Shows evidence of tolerance or physical dependency on opioid analgesics or sedative-hypnotic medications.
• Has a urine drug screen that tests positive for drugs of abuse or misuse, including cannabinoids.
• Has liver function test results greater than 3x the upper limit of normal or a history of cirrhosis.
• Has any clinically significant unstable cardiac disease (eg, uncontrolled hypertension, clinically significant arrhythmia at baseline, or an implantable cardioverter-defibrillator \[ICD\])
• Has any clinically significant unstable neurological, immunological, renal, or hematological disease (eg, uncontrolled diabetes or significantly abnormal laboratory findings), or any other condition that, in the opinion of the investigator, could compromise the patient's welfare, ability to communicate with the study staff or otherwise contraindicate study participation.
• Has an open workman's compensation claim.

Sponsors & Collaborators

• Innocoll: lead

Study Sites (23)

Unknown Facility

Mobile, Alabama, 36617, United States

Location

Unknown Facility

Sheffield, Alabama, 35660, United States

Location

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Phoenix, Arizona, 85023, United States

Location

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Little Rock, Arkansas, 72205, United States

Location

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Encino, California, 91436, United States

Location

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Bradenton, Florida, 34206, United States

Location

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Clermont, Florida, 34711, United States

Location

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Inverness, Florida, 34452, United States

Location

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Kissimmee, Florida, 34741, United States

Location

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Miami, Florida, 33136, United States

Location

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Miami, Florida, 33144, United States

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Orlando, Florida, 32825, United States

Location

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St. Petersburg, Florida, 33713, United States

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Tampa, Florida, 33606, United States

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Unknown Facility

Weston, Florida, 33331, United States

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Indianapolis, Indiana, 46202, United States

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Springfield, Massachusetts, 01199, United States

Location

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Flint, Michigan, 48532, United States

Location

Unknown Facility

Las Vegas, Nevada, 89102, United States

Location

Unknown Facility

Las Vegas, Nevada, 89106, United States

Location

Unknown Facility

El Paso, Texas, 79935, United States

Location

Unknown Facility

Houston, Texas, 77054, United States

Location

Unknown Facility

Lampasas, Texas, 76550, United States

Location

Related Publications (1)

• Velanovich V, Rider P, Deck K, Minkowitz HS, Leiman D, Jones N, Niebler G. Safety and Efficacy of Bupivacaine HCl Collagen-Matrix Implant (INL-001) in Open Inguinal Hernia Repair: Results from Two Randomized Controlled Trials. Adv Ther. 2019 Jan;36(1):200-216. doi: 10.1007/s12325-018-0836-4. Epub 2018 Nov 22.

  PMID: 30467808 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
• Organization: Innocoll

ctucker@innocoll.com

484-406-5211

Study Officials

• Gwendolyn Niebler, D.O.

  Innocoll

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 14, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 8, 2021
• Results First Posted: January 8, 2021

Record last verified: 2021-01

Locations

US (23)