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Trial record 1 of 4 for:    xaracoll
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Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty (MATRIX-2)

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ClinicalTrials.gov Identifier: NCT02525133
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Innocoll

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: XaraColl Other: Placebo Phase 3

Detailed Description:

This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study in adults who are scheduled for unilateral inguinal hernioplasty via open laparotomy (tension-free technique). Patients will receive either 3 XaraColl Bupivacaine Implants each containing 100 mg of bupivacaine hydrochloride, for a 300 mg total dose; or 3 placebo-sponges.

Three test article sponges will be implanted according to the patient's blinded treatment assignment. Following surgery, patients will be transferred to a postanesthesia care unit (PACU) and/or other postoperative recovery area for observation where they may receive parenteral morphine as needed (rescue medication for breakthrough pain) and on request for pain control. Once patients can tolerate oral medication, they will commence a standardized oral analgesic regimen with additional PRN medication to manage breakthrough pain only when it occurs.

Patients will assess their postoperative pain intensity (PI) using an 11-point numerical rating scale (NRS) from 0 hour through 72 hours postoperatively.

Patients will be observed postoperatively for a minimum of 3 hours and may be discharged at any time following completion of their 3-hour vital sign and PI assessments. Patients will be contacted at approximately 6, 24 and 48 hours after implantation to ensure protocol compliance and to perform safety assessments (including AEs and concomitant medications). At 72 hours, patients will return to the clinic to perform their final PI assessment, complete a categorical assessment of their overall pain control, and for follow-up safety assessments. They will also be asked to record the incidence of any ongoing or subsequent AEs (and any associated treatment) through Day 7. Additional follow-up assessments for safety will be performed at postoperative Day 7 (telephone call) and Days 15 and 30 (clinic visits).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 319 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the XaraColl® Bupivacaine Implant (300 mg Bupivacaine Hydrochloride) After Open Laparotomy Hernioplasty
Study Start Date : August 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: XaraColl
3 XaraColl Bupivacaine Implants each containing 100 mg of bupivacaine hydrochloride, for a 300 mg total dose
Drug: XaraColl
Surgical implantation of 3 bupivacaine collagen implants
Other Name: Bupivacaine collagen implant

Placebo Comparator: Placebo
3 placebo implants
Other: Placebo
Plain collagen implant (vehicle)
Other Name: Collagen implant




Primary Outcome Measures :
  1. SPID24 [ Time Frame: 0 to 24 hours ]
    Sum of pain intensity difference (SPID). 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). For the purpose of SPID computation, PI at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation. SPID will not be calculated for randomized but not treated patients.


Secondary Outcome Measures :
  1. TOpA24 [ Time Frame: Time 0 through 24 hours ]
    Total use of opioid analgesia (TOpA) from Time 0 through 24 hours (TOpA24)

  2. TOpA48 [ Time Frame: Time 0 through 48 hours ]
    Total use of opioid analgesia (TOpA) from Time 0 through 48 hours (TOpA24)

  3. TOpA72 [ Time Frame: Time 0 through 72 hours ]
    Total use of opioid analgesia (TOpA) from Time 0 through 72 hours (TOpA24)

  4. SPID48 [ Time Frame: 0 to 48 hours ]
    Sum of pain intensity difference (SPID). The time weighted sum of pain intensity from 0 to 24 hours (ie, the area under the NRS PI curve from 0 to 48 hours). For the purpose of SPID computation, PI at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation.

  5. SPID72 [ Time Frame: 0 to 72 hours ]
    Sum of pain intensity difference (SPID). The time weighted sum of pain intensity from 0 to 72 hours (ie, the area under the NRS PI curve from 0 to 48 hours). For the purpose of SPID computation, PI at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Has participated in a clinical trial (investigational or marketed product) within 30 days of surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02525133


Locations
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United States, Alabama
Anniston, Alabama, United States, 36207
Birmingham, Alabama, United States, 35216
United States, California
Anaheim, California, United States, 92801
Laguna Hills, California, United States, 92653
Pasadena, California, United States, 91105
Placentia, California, United States, 92870
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Miami, Florida, United States, 33134
Miami, Florida, United States, 33155
Pembroke Pines, Florida, United States, 33028
Pensacola, Florida, United States, 32503
United States, Georgia
Columbus, Georgia, United States, 31904
United States, Illinois
Chicago, Illinois, United States, 60645
United States, Nevada
Las Vegas, Nevada, United States, 89104
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland, Ohio, United States, 44106
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Houston, Texas, United States, 77004
Houston, Texas, United States, 77024
United States, Utah
Salt Lake City, Utah, United States, 84124
United States, Virginia
Newport News, Virginia, United States, 23606
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Innocoll
Investigators
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Study Director: Nigel Jones Vice President, Global Clinical Operations, Innocoll Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Innocoll
ClinicalTrials.gov Identifier: NCT02525133    
Other Study ID Numbers: INN-CB-016
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Keywords provided by Innocoll:
post operative pain
hernioplasty
bupivacaine
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents