Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy

NCT01220024 | Completed Phase 2 Results

• 1 other identifier: INN-CB-010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Conditions

Herniorrhaphy; Postoperative Pain; Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores.

  The primary efficacy variable was SPI defined as area under the curve (AUC) of 100-mm VAS pain intensity scores after aggravated movement (cough) from 1 to 72 hours after surgery. Minimum score is "0". Maximum score is 7200. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. A lower score means a better outcome or less pain reported.

  1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.

Secondary Outcomes (5)

• Sum of Pain Intensity (SPI) After Aggravated Movement (Cough)

  1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.

• Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest

  1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.

• Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough)

  1,2,4,6,8,10,12,24,48 and 72 hours

• Pain Intensity VAS Scores Over Time at Rest

  1,2,4,6,8,10,12,24,48 and 72 hours

• Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement

  1,2,4,6,8,10,12,24,48 and 72 hours

Study Arms (2)

2, 5x5cm bupivacaine collagen sponges

EXPERIMENTAL

collagen sponges

Drug: Bupivacaine Collagen Sponge

2, Placebo collagen sponges

PLACEBO COMPARATOR

Placebo collagen sponges

Drug: Placebo collagen Sponge

Interventions

Bupivacaine Collagen Sponge DRUG

Drug: Bupivacaine Collagen Sponge

Also known as: Bupivacaine Implant

2, 5x5cm bupivacaine collagen sponges

Placebo collagen Sponge DRUG

Drug: Placebo Collagen Sponge

Also known as: Collagen Implant

2, Placebo collagen sponges

Eligibility Criteria

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

You may qualify if:

• Man ≥ 18 years
• Body mass index (BMI) ≥ 19 and ≤ 40 kg/m2.
• Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free technique) to be performed according to standard surgical technique under general anesthesia.

You may not qualify if:

• Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
• Scheduled for bilateral inguinal herniorrhaphy.
• Undergone a prior herniorrhaphy on the side scheduled for repair.
• Undergone major surgery within 3 mos of the scheduled herniorrhaphy.
• Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
• Concomitantly uses antiarrhythmics (eg, amiodarone, lidocaine), propranolol, or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).
• Used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery but are subject to preoperative restrictions for oral intake.

Sponsors & Collaborators

• Innocoll: lead
• Premier Research: collaborator

Study Sites (1)

Unknown Facility

Bellaire, Texas, 77401, 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

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal

Interventions

Bupivacaine; Collagen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

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: September 23, 2010
• First Posted: October 13, 2010
• Study Start: December 2, 2010
• Primary Completion: May 18, 2011
• Study Completion: May 18, 2011
• Last Updated: March 10, 2021
• Results First Posted: March 10, 2021

Record last verified: 2021-02

Locations

US (1)