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

NCT00626886 | Completed Phase 2 Results

• 1 other identifier: INN-CB-003
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Inguinal Hernia

Keywords

Herniorrhaphy; Inguinal Hernia Repair; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Total Use of Opioid Rescue Analgesia Over 0 to 24 Hours

  Total Use of Opioid Rescue Analgesia (mg) Over 0 to 24 Hour - number count - higher score means worse outcome

  0 to 24 hours postoperatively

Secondary Outcomes (9)

• Total Use of Opioid Rescue Analgesia Over 0 to 48 Hours

  0 to 48 hours postoperatively

• Total Use of Opioid Rescue Analgesia Over 0 to 72 Hours

  0 to 72 hours postoperatively

• Summed Pain Intensity VAS Scores (VAS at Rest and After Cough)

  1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0

• Patient's Global Evaluation of the Study Treatment on a 5 Point Likert Scale

  At 72 hours after time 0

• VAS Pain Intensity Scores Over Time

  At 1, 1.5, 2,3,4,5,6,24,48,72 Hours

Study Arms (2)

1

EXPERIMENTAL

Two, 5x5cm bupivacaine collagen sponges implanted during surgery

Drug: Bupivacaine Collagen Sponge

2

PLACEBO COMPARATOR

Placebo collagen sponge implanted during surgery

Drug: placebo collagen sponge

Interventions

Bupivacaine Collagen Sponge DRUG

collagen; Bupivacaine hydrocholoride

Also known as: CollaRx Bupivacaine Implant

1

placebo collagen sponge DRUG

collagen

Also known as: Placebo

2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innocoll: lead
• Premier Research: collaborator

Study Sites (1)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Related Publications (1)

• Cusack SL, Jaros M, Kuss M, Minkowitz HS, Winkle P, Hemsen L. Clinical evaluation of XaraColl((R)), a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies. J Pain Res. 2012;5:217-25. doi: 10.2147/JPR.S33453. Epub 2012 Jun 27.

  PMID: 22792007 RESULT

Related Links

• Clinical evaluation of a Bupivacaine-Collagen Implant (XaraColl®) for postoperative analgesia from two multicenter, randomized, double-blind, placebo-controlled pilot studies

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal

Condition Hierarchy (Ancestors)

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

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

• David Prior

  Innocoll

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 29, 2008
• Study Start: March 11, 2008
• Primary Completion: January 29, 2009
• Study Completion: January 29, 2009
• Last Updated: January 11, 2021
• Results First Posted: January 11, 2021

Record last verified: 2021-01

Locations

US (1)