A Safety and Effectiveness Study of SABER™-Bupivacaine for Pain Following Shoulder Surgery

This study has been completed.
Sponsor:
Collaborator:
Nycomed
Information provided by:
Durect
ClinicalTrials.gov Identifier:
NCT00818363
First received: January 5, 2009
Last updated: February 4, 2010
Last verified: February 2010
  Purpose

This is a research study testing SABER™-Bupivacaine (an experimental pain-relieving medication). SABER™-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain.

The purpose of this study is to investigate safety (if there are any side effects) associated with the use of SABER™-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.


Condition Intervention Phase
Postoperative Pain
Drug: SABER™-Bupivacaine
Drug: SABER™-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, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Multi-Center, Placebo-Controlled Trial of SABER™-Bupivacaine for Post-Operative Pain Control and Opioid Sparing/Opioid-Related Adverse Event Reduction Following Arthroscopic Shoulder Surgery

Resource links provided by NLM:


Further study details as provided by Durect:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: 0 to 3 days post-dose ] [ Designated as safety issue: No ]
  • Supplemental opioid use [ Time Frame: 0 to 3 days post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of opioid related side effects [ Time Frame: 0 to 14 days post-dose ] [ Designated as safety issue: No ]
  • Pain Intensity [ Time Frame: 0 to 2 days post-dose ] [ Designated as safety issue: No ]
  • Supplemental opioid use [ Time Frame: 0 to 2 days post-dose ] [ Designated as safety issue: No ]
  • Time-to-first use of opioid supplemental pain medication [ Time Frame: 0 to 14 days post-dose ] [ Designated as safety issue: No ]
  • Severity of opioid-related side effects [ Time Frame: 0 to 14 days post-dose ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: SABER™-Bupivacaine
5.0 mL SABER™-Bupivacaine/Once
Drug: SABER™-Bupivacaine
Injectable Extended Release Solution; 5.0 mL SABER™-Bupivacaine/Once
Placebo Comparator: Group 2: SABER™-Placebo
5.0 mL SABER™-Placebo/Once
Drug: SABER™-Placebo
Injectable Solution; 5.0 mL SABER™-Placebo/Once

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be able to read and understand the consent form, provide written consent, complete trial-related procedures, and communicate with the trial staff.
  • Males and females, 18 to 65 years of age, scheduled for shoulder surgery.
  • Patients must be healthy or have only mild systemic disease.
  • Patients must have ECG wave form within normal limits
  • Patients must have blood pressure within normal range.
  • Male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed.
  • Patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial.

Exclusion Criteria:

  • Patients with previous arthroscopic surgery or open surgery on the study shoulder.
  • Patients with chronic pain conditions requiring continuous use of corticosteroids for greater than 3 months.
  • Patients with fibromyalgia, rheumatoid arthritis, and/or sero-negative inflammatory arthropathies.
  • Patients with a below normal calculated creatinine clearance.
  • Patients who are pregnant or lactating.
  • Patients currently receiving more than 20 mg of hydrocodone daily (or equivalent narcotic dose) on routine basis.
  • Patients, who in the Investigator's opinion, have developed opioid tolerance.
  • Patients with current or regular use of anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors at screening.
  • Patients with current or regular use of drugs known to significantly prolong the QTc interval
  • Patients with known hypersensitivity to local anesthetic agents of the amide type (e.g., lidocaine, bupivacaine).
  • Patients with known hypersensitivity to opioids.
  • Patients with conditions contraindicated for use of opioids.
  • Patients with known or suspected abuse of opioids or other illicit drugs.
  • Patients with known or suspected alcohol abuse.
  • Participation in another clinical trial at the same time or within 30 days of this trial.
  • Patients who, in the Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason.
  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: NCT00818363

Locations
Australia, New South Wales
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Kippa Ring, Queensland, Australia, 4021
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Toorak Gardens, South Australia, Australia, 5065
Australia, Victoria
Geelong, Victoria, Australia, 3220
Hampton, Victoria, Australia, 3188
Ringwood East, Victoria, Australia, 3135
New Zealand
Christchurch, New Zealand
Hamilton, New Zealand
Sponsors and Collaborators
Durect
Nycomed
Investigators
Study Director: Dmitri Lissin, MD Durect Corporation
  More Information

No publications provided by Durect

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janine Wong, Senior CRA, DURECT Corporation
ClinicalTrials.gov Identifier: NCT00818363     History of Changes
Other Study ID Numbers: C803-017
Study First Received: January 5, 2009
Last Updated: February 4, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe

Keywords provided by Durect:
Postoperative pain
shoulder surgery
opioid

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Analgesics, Opioid
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
Narcotics
Analgesics

ClinicalTrials.gov processed this record on August 18, 2014