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

This study has been terminated.
(Business decision)
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by:
Innocoll Technologies
ClinicalTrials.gov Identifier:
NCT00661466
First received: April 15, 2008
Last updated: September 12, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Drug: Bupivacaine Collagen Sponge
Drug: Placebo
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 Patients After Gastrointestinal Surgery

Resource links provided by NLM:


Further study details as provided by Innocoll Technologies:

Primary Outcome Measures:
  • The total amount of opioid rescue analgesia used [ Time Frame: 0 to 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The total amount of opioid rescue analgesia used [ Time Frame: 0 to 48 hours postoperatively ] [ Designated as safety issue: No ]
  • The total amount of opioid rescue analgesia used [ Time Frame: 0 to 72 hours postoperatively ] [ Designated as safety issue: No ]
  • Pain intensity rating on the Visual Analogue Scale (VAS) [ 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 scale [ Time Frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively ] [ Designated as safety issue: No ]
  • Pain relief rating on a 5-point scale [ 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 global evaluation of study treatment on a 5-point 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 from time 0 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters [ Time Frame: 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively ] [ Designated as safety issue: Yes ]
  • The incidence of treatment-emergent Adverse Events [ Time Frame: Through 30 days after surgery ] [ Designated as safety issue: Yes ]
  • Changes in vital sign measurements [ Time Frame: Through 72 hours post insertion ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: April 2008
Study Completion Date: February 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Placebo Comparator: 2
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
placebo

Detailed Description:

Gastrointestinal (GI) surgery encompasses a range of surgical procedures that involve abdominal incision. Gastrointestinal surgery may be performed to treat an abdominal aortic aneurysm, ulcerative colitis, Crohn's disease, gallbladder disease, bile duct disease and morbid obesity. Although less invasive laparoscopic procedures are performed when warranted, open abdominal surgery is required for certain indications and for more complicated or advanced cases.

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 for 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 the CollaRx Bupivacaine implant or a plain collagen sponge.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  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: NCT00661466

Locations
United States, New York
Albany Medical Center Hospital
Albany, New York, United States, 12208
Sponsors and Collaborators
Innocoll Technologies
Premier Research Group plc
Investigators
Study Director: David Prior Innocoll Technologies
  More Information

No publications provided

Responsible Party: David Prior, Innocoll Holdings Inc.
ClinicalTrials.gov Identifier: NCT00661466     History of Changes
Other Study ID Numbers: INN-CB-004
Study First Received: April 15, 2008
Last Updated: September 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Innocoll Technologies:
Gastrointestinal surgery
Post operative pain

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

ClinicalTrials.gov processed this record on October 01, 2014