Efficacy and Safety of A Collagen Bupivacaine Implant in Patients After Gastrointestinal Surgery

NCT00661466 | Terminated Phase 2 Results

• 1 other identifier: INN-CB-004
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the CollaRx Bupivacaine Implant (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after gastrointestinal (GI) surgery.

Conditions

Pain, Postoperative

Keywords

Gastrointestinal surgery; Post operative pain

Outcome Measures

Primary Outcomes (1)

• The Total Amount of Opioid Rescue Analgesia Used

  Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.

  0 to 24 hours postoperatively

Secondary Outcomes (10)

• The Total Amount of Opioid Rescue Analgesia Used

  0 to 48 hours postoperatively

• The Total Amount of Opioid Rescue Analgesia Used

  0 to 72 hours postoperatively

• Pain Intensity Rating on the Visual Analogue Scale (VAS)

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

• Pain Intensity Rating on a 4-point Scale

  At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively

• Pain Relief Rating on a 5-point Scale

  At 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 24, 48 and 72 hours after Time 0

Study Arms (2)

1

EXPERIMENTAL

Either three or four 5x5-cm bupivacaine sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.

Drug: Bupivacaine Collagen Sponge

2

PLACEBO COMPARATOR

Either three or four 5x5-cm placebo sponges implanted at 2 sites within the surgical field (1) over the abdominal viscera and under the fascia prior to closing the fascia and (2) in the subcutaneous tissue just under the skin incision.

Drug: Placebo

Interventions

Bupivacaine Collagen Sponge DRUG

1

Placebo DRUG

placebo

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a man or woman who is ≥ 18 and ≤ 75 years of age.
• Has a body mass index (BMI) \> 19 and \< 40 kg/m2.
• Has a planned elective surgery that requires a vertical or transverse abdominal incision (including but not limited to abdominal aortic aneurysm repair, cholecystectomy and simple bowel resection) to be performed according to standard surgical technique under general anesthesia.
• Has a risk classification of I, II or III according to the American Society of Anesthesiologists (ASA)
• If female, is nonpregnant (negative pregnancy test at Screening and Day 0 before surgery) and nonlactating.
• If female, is either not of childbearing potential or practicing a defined medically acceptable method of birth control and agrees to continue with the regimen throughout the study.
• Is free of other physical or mental conditions that, in the opinion of the Investigator, may confound quantification of postoperative pain resulting from the surgery.
• Has the ability and willingness to comply with the study procedures and the use of the pain scales; is deemed capable of operating a PCA device; and is able to communicate meaningfully with the study staff.
• Must voluntarily sign and date an informed consent form (ICF) that is approved by an IRB prior to 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 known hypersensitivity to amide local anesthetics, opioids or bovine products, or to inactive ingredients of the test article.
• Has 1 of the following surgical procedures planned: total abdominal hysterectomy, omentectomy or surgical procedure for staging cancer.
• Requires the use of Seprafilm® or other absorbable adhesion barriers for the GI surgery.
• Requires any additional surgical procedures either related or unrelated to the GI surgery during the same hospitalization.
• Is required to receive neuraxial (spinal or epidural) opioid analgesics during the study.
• Has cardiac arrhythmia 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 but are 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 prior to Screening.
• Has undergone another major surgery within 3 months of the GI surgery.
• 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.

Sponsors & Collaborators

• Innocoll: lead
• Premier Research: collaborator

Study Sites (1)

Albany Medical Center Hospital

Albany, New York, 12208, United States

Location

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

• David Prior

  Innocoll

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: April 15, 2008
• First Posted: April 18, 2008
• Study Start: July 24, 2008
• Primary Completion: January 10, 2009
• Study Completion: February 10, 2009
• Last Updated: November 3, 2020
• Results First Posted: November 3, 2020

Record last verified: 2020-09

Locations

US (1)