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

This study has been completed.
Sponsor:
Collaborator:
Nycomed
Information provided by (Responsible Party):
Durect
ClinicalTrials.gov Identifier:
NCT00818363
First received: January 5, 2009
Last updated: August 20, 2014
Last verified: August 2014

January 5, 2009
August 20, 2014
December 2008
October 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00818363 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Safety and Effectiveness Study of SABER™-Bupivacaine for Pain Following Shoulder Surgery
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain
  • Drug: SABER™-Bupivacaine
    Injectable Extended Release Solution; 5.0 mL SABER™-Bupivacaine/Once
  • Drug: SABER™-Placebo
    Injectable Solution; 5.0 mL SABER™-Placebo/Once
  • Experimental: Group 1: SABER™-Bupivacaine
    5.0 mL SABER™-Bupivacaine/Once
    Intervention: Drug: SABER™-Bupivacaine
  • Placebo Comparator: Group 2: SABER™-Placebo
    5.0 mL SABER™-Placebo/Once
    Intervention: Drug: SABER™-Placebo
Hadj A, Hadj A, Hadj A, Rosenfeldt F, Nicholson D, Moodie J, Turner R, Watts R, Fletcher I, Abrouk N, Lissin D. Safety and efficacy of extended-release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial. ANZ J Surg. 2012 Apr;82(4):251-7. doi: 10.1111/j.1445-2197.2011.05754.x. Epub 2011 Jun 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2009
October 2009   (final data collection date for primary outcome measure)

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 corrected QT 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand
 
NCT00818363
C803-017
No
Durect
Durect
Nycomed
Study Director: Dmitri Lissin, MD Durect Corporation
Durect
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP