An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery

This study has been completed.
Sponsor:
Collaborators:
Nycomed
Hospira, Inc.
Information provided by:
Durect
ClinicalTrials.gov Identifier:
NCT01139866
First received: May 25, 2010
Last updated: July 13, 2011
Last verified: July 2011
  Purpose

This is an extension to a previous research trial testing SABER™-Bupivacaine (an experimental pain-relieving medication). The purpose of this extension trial is to assess whether treatment with SABER™-Bupivacaine or SABER™-Placebo has had any effect on healing of the participant's shoulder, wound, or the skin near their scar. This trial will also assess safety (side effects).


Condition
Pain

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Multi-Center, Prospective, Observational, Extension Trial Following DURECT Protocol C803-017 to Investigate the Long-term Safety of SABER™-Bupivacaine Following Arthroscopic Shoulder Surgery

Resource links provided by NLM:


Further study details as provided by Durect:

Primary Outcome Measures:
  • Safety Summaries: Pain Intensity on Movement Evaluation; Surgical Site Healing and Local Tissue Evaluation; Shoulder Examination; MRI; Medical History Update; Adverse Events; and Concomitant Medications [ Time Frame: 18 months post-dose in C803-017 trial ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: June 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1: SABER™-Bupivacaine
Received 5.0 mL SABER™-Bupivacaine in previous C803-017 trial
Group 2: SABER™-Placebo
Received 5.0 mL SABER™-Placebo in previous C803-017 trial

Detailed Description:

This research trial will involve all available subjects who received treatment in DURECT Protocol C803-017. All subjects will have the same follow-up safety assessments performed. No experimental treatment will be given in this trial. Subjects, Investigators, and caregivers will remain blinded to the treatment subjects received in the previous trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All available subjects who received treatment in DURECT protocol C803-017.

Criteria

Inclusion Criteria:

  • Participants must have provided written consent to participate in the trial prior to any trial procedures and understand that they are free to withdraw from the trial at any time.
  • Participants must be able to read and understand the consent form, complete trial-related procedures, and communicate with the trial staff.
  • Participants must have participated in DURECT Protocol C803-017 and received SABER™-Bupivacaine or SABER™-Placebo approximately 18 months before enrolling in this trial.

Exclusion Criteria:

  • Participants who participated in any other trial with an investigational drug or device since their participation in DURECT protocol C803-017.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139866

Locations
Australia, New South Wales
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Auchenflower, Queensland, Australia, 4066
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Toorak Gardens, South Australia, Australia, 5065
Australia, Victoria
Geelong, Victoria, Australia, 3220
Ringwood East, Victoria, Australia, 3135
New Zealand
Christchurch, New Zealand, 8014
Hamilton, New Zealand
Sponsors and Collaborators
Durect
Nycomed
Hospira, Inc.
Investigators
Study Director: Dmitri Lissin, MD Durect Corporation
  More Information

No publications provided

Responsible Party: Christina Blevins, Clinical Research Associate, DURECT Corporation
ClinicalTrials.gov Identifier: NCT01139866     History of Changes
Other Study ID Numbers: C803-017e
Study First Received: May 25, 2010
Last Updated: July 13, 2011
Health Authority: Australia: Human Research Ethics Committee
New Zealand: Health Research Council

Keywords provided by Durect:
Long-term Safety
Shoulder Surgery
bupivacaine

Additional relevant MeSH terms:
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 April 17, 2014