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

NCT00818363 | Completed Phase 2 Results

• 1 other identifier: C803-017
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 9

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

Postoperative pain; shoulder surgery; opioid

Outcome Measures

Primary Outcomes (2)

• Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose.

  Mean pain intensity on movement AUC (time normalized area under the curve) during the period 0 to 72 hours post-dose. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.

  0 to 72 hours post-dose

• Supplemental Opioid Use

  Mean total morphine-equivalent dose during the period 0 to 72 hours post-dose

  0 to 72 hours post-dose

Secondary Outcomes (5)

• Number (Frequency) of Participants Reporting Opioid-related Adverse Events

  0 to 72 hours post-dose

• Mean Pain Intensity on Movement AUC (Time-normalized AUC) During the Period 0 to 48 Hours Post-dose (0 to 2 Days Post-dose).

  0 to 48 hours post-dose

• Supplemental Opioid Use

  0 to 48 hours post-dose

• Time-to-first Use of Opioid Supplemental Pain Medication

  0 to 14 days post-dose

• Severity of Opioid-related Side Effects

  0 to 14 days post-dose

Study Arms (2)

Group 1: SABER-Bupivacaine

EXPERIMENTAL

5.0 mL SABER-Bupivacaine/Once

Drug: SABER-Bupivacaine

Group 2: SABER-Placebo

PLACEBO COMPARATOR

5.0 mL SABER-Placebo/Once

Drug: SABER-Placebo

Interventions

SABER-Bupivacaine DRUG

Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once

Also known as: POSIMIR® bupivacaine solution

Group 1: SABER-Bupivacaine

SABER-Placebo DRUG

Injectable Solution; 5.0 mL SABER-Placebo/Once

Group 2: SABER-Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Durect: lead
• Nycomed: collaborator

Study Sites (9)

Unknown Facility

Westmead, New South Wales, 2145, Australia

Location

Unknown Facility

Kippa-Ring, Queensland, 4021, Australia

Location

Unknown Facility

Adelaide, South Australia, 5000, Australia

Location

Unknown Facility

Toorak Gardens, South Australia, 5065, Australia

Location

Unknown Facility

Geelong, Victoria, 3220, Australia

Location

Unknown Facility

Hampton, Victoria, 3188, Australia

Location

Unknown Facility

Ringwood East, Victoria, 3135, Australia

Location

Unknown Facility

Christchurch, New Zealand

Location

Unknown Facility

Hamilton, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 22510183 DERIVED

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: Deborah Scott
• Organization: Durect Corporation

deborah.scott@durect.com

408-777-1417

Study Officials

• Dmitri Lissin, MD

  Durect

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 7, 2009
• Study Start: December 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 1, 2021
• Results First Posted: June 1, 2021

Record last verified: 2021-05

Locations

NZ (2); AU (7)