Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy

This study has been completed.
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Innocoll Technologies
ClinicalTrials.gov Identifier:
NCT00626886
First received: February 20, 2008
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after herniorrhaphy.


Condition Intervention Phase
Postoperative Pain
Inguinal Hernia
Drug: Bupivacaine Collagen Sponge
Drug: placebo collagen sponge
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Single Dose, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Pharmacokinetic Profile of the CollaRx® Bupivacaine Implant in Men After Open Mesh Herniorrhaphy

Resource links provided by NLM:


Further study details as provided by Innocoll Technologies:

Primary Outcome Measures:
  • Total use of opioid rescue analgesia [ Time Frame: 0 to 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total use of opioid rescue analgesia [ Time Frame: 0 to 48 hours postoperatively ] [ Designated as safety issue: No ]
  • Total use of opioid rescue analgesia [ Time Frame: 0 to 72 hours postoperatively ] [ Designated as safety issue: No ]
  • Pain intensity on the VAS at rest and after aggravated movement (cough) [ Time Frame: 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0 ] [ Designated as safety issue: No ]
  • Pain intensity rating on a 4-point Likert scale at rest and after aggravated movement (cough) [ Time Frame: At 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0 ] [ Designated as safety issue: No ]
  • Pain relief rating on a 5-point Likert scale at rest and after aggravated movement (cough) [ Time Frame: At 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0 ] [ Designated as safety issue: No ]
  • Patient's global evaluation of the study treatment on a 5 point Likert scale [ Time Frame: At 72 hours after time 0 ] [ Designated as safety issue: No ]
  • Time to first use of opioid rescue analgesia [ Time Frame: actual time ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters [ Time Frame: at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0 ] [ Designated as safety issue: No ]
  • Treatment emergent adverse events [ Time Frame: Through 30 days after surgery ] [ Designated as safety issue: Yes ]
  • Vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure and body temperature) [ Time Frame: Screening, Baseline and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0 ] [ Designated as safety issue: Yes ]

Enrollment: 53
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Two, 5x5cm bupivacaine collagen sponges implanted during surgery
Drug: Bupivacaine Collagen Sponge
collagen; Bupivacaine hydrocholoride
Other Name: CollaRx Bupivacaine Implant
Placebo Comparator: 2
Placebo collagen sponge implanted during surgery
Drug: placebo collagen sponge
collagen
Other Name: Placebo

Detailed Description:

Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.

Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.

This study will compare the amount of narcotic pain medication required after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has body mass index (BMI) > 19 and < 40 kg/m2.
  • Has a planned unilateral inguinal herniorrhaphy (open mesh, tension free technique) to be performed according to standard surgical technique under general anesthesia.
  • Has a risk classification of I, II or III according to the ASA.
  • Is free of other physical or mental conditions that, in the opinion of the Investigator, may confound the quantification of postoperative pain after herniorrhaphy.
  • Has the ability and willingness to comply with the study procedures and the use of the pain scales.
  • Is willing to use only permitted medications and anesthetics throughout the study.
  • Is willing to use opioid rescue analgesia for moderate to severe incisional pain only.
  • Must voluntarily sign and date an informed consent form (ICF) that is approved by an Institutional Review Board (IRB) before the conduct of any study specific procedures.
  • Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.

Exclusion Criteria:

  • Has a known hypersensitivity to amide local anesthetics, opioids, bovine products or inactive ingredients of the test article.
  • Is scheduled for bilateral inguinal herniorrhaphy.
  • Has undergone a prior herniorrhaphy on the side that is currently scheduled for repair.
  • Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
  • Concomitantly uses antiarrhythmics (eg, amiodarone), propranolol or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).
  • Has used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery
  • 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 undergone major surgery within 3 months of the scheduled herniorrhaphy.
  • Has known or suspected history of alcohol or drug abuse or misuse within 3 years of Screening or evidence of tolerance or physical dependency on opioid analgesics or sedative-hypnotic medications.
  • Has used opioids or tramadol on an extended daily basis (> 7 days) before surgery. Patients who, in the Investigator's opinion, are developing opioid tolerance are to be excluded.
  • Has impaired liver function, aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin ≥ 3.0 times the upper limit of normal (ULN), active hepatic disease, evidence of clinically significant liver disease or another condition (eg, alcoholism, cirrhosis or hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with exposure to test article.
  • Has any clinically significant unstable cardiac, neurological, immunological, renal or hematological disease 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.
  • Is judged by the Investigator to be at risk for infection or slow wound healing.
  • Has a chronic painful condition that might confound the assessment of pain associated with the herniorrhaphy.
  • Routinely uses pain medication that, in the opinion of the Investigator, could confound the pain assessments during the study.
  • Has been treated with agents that could affect the analgesic response (such as central alpha agents, neuroleptic agents and other antipsychotic agents) within 2 weeks of surgery.
  • Has been treated with monoamine oxidase inhibitors (MAOIs) within 10 days of surgery.
  • Has been treated with systemic corticosteroids within 7 days of surgery (inhaled and topical corticosteroids are allowed).
  • Has participated in a clinical trial within 30 days of surgery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626886

Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Sponsors and Collaborators
Innocoll Technologies
Premier Research Group plc
Investigators
Study Director: David Prior Innocoll Technologies
  More Information

Additional Information:
Publications:
Responsible Party: Innocoll Technologies
ClinicalTrials.gov Identifier: NCT00626886     History of Changes
Other Study ID Numbers: INN-CB-003
Study First Received: February 20, 2008
Last Updated: April 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Innocoll Technologies:
Herniorrhaphy
Inguinal Hernia Repair
Postoperative pain

Additional relevant MeSH terms:
Hernia, Inguinal
Pain, Postoperative
Hernia
Hernia, Abdominal
Pain
Pathologic Processes
Pathological Conditions, Anatomical
Postoperative Complications
Signs and Symptoms
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014