A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair

NCT00974350 | Completed Phase 2 Results

• 1 other identifier: CLIN803-006-0006
• Study Type: interventional
• Target: 124
• Locations: 2 countries
• Sites: 5

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. This study is testing SABER-Bupivacaine in people having surgery to repair a hernia. The purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of SABER-Bupivacaine with SABER-Placebo.

Conditions

Postoperative Pain; Hernia; Surgery

Keywords

Post-operative pain; hernia surgery; opioid

Outcome Measures

Primary Outcomes (2)

• Pain Intensity on Movement

  Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.

  1 to 72 hours post-dose

• Proportion (Percent) of Patients Using Supplemental Opioids

  0 to 14 days post-dose

Secondary Outcomes (4)

• Pain Intensity

  1 to 48 hours post-dose

• Treatment Satisfaction

  1 to 5 days post-dose

• Supplemental Opioid Use

  0 to 14 days post-dose

• Mean Function Activities (Modified Brief Pain Inventory)

  1 to 5 days post-dose

Study Arms (3)

Group 1: SABER-Bupivacaine

EXPERIMENTAL

2.5 mL SABER-Bupivacaine/Once

Drug: SABER-Bupivacaine

Group 2: SABER-Bupivacaine

EXPERIMENTAL

5.0 mL SABER-Bupivacaine/Once

Drug: SABER-Bupivacaine

Group 3: SABER-Placebo

PLACEBO COMPARATOR

2.5 mL or 5.0 mL SABER-Placebo/Once

Drug: SABER-Placebo

Interventions

SABER-Bupivacaine DRUG

Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once

Group 1: SABER-Bupivacaine

SABER-Placebo DRUG

Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once

Group 3: 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:

• Males and females, 18 to 65 years of age, scheduled for hernia repair surgery
• Patients must be in good health prior to study participation
• Patients must have blood pressure within normal range or with Stage 1 high blood pressure
• 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
• Ability to read, understand, communicate, and voluntarily sign the informed consent form prior to any trial specific procedures

You may not qualify if:

• Patients with previous abdominal surgery scar tissue
• Patients with clinically significant abnormalities of any body system unrelated to the disease under study
• Connective tissue disorders
• Patients who are pregnant or lactating
• Current or regular use of analgesic medication for other indications
• Patients with current or regular use of antidepressants or monoamine oxidase inhibitors at screening
• Use of any drugs or medication that may interfere with the study and its results
• Patients with known hypersensitivity to the study drugs or their components
• Patients with known or suspected alcohol abuse or illicit drug use
• Participation in another clinical trial at the same time or within 30 days of this trial
• Patient is unwilling to comply with the study procedures

Sponsors & Collaborators

• Durect: lead
• Nycomed: collaborator

Study Sites (5)

Unknown Facility

Cairns, Queensland, 4870, Australia

Location

Unknown Facility

Sunnybank, Queensland, 4109, Australia

Location

Unknown Facility

Port Lincoln, South Australia, 5606, Australia

Location

Unknown Facility

Ringwood East, Victoria, 3135, Australia

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 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Hernia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Anatomical

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

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 10, 2009
• Study Start: January 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: May 27, 2021
• Results First Posted: May 5, 2021

Record last verified: 2021-05

Locations

NZ (1); AU (4)