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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01139866
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : July 15, 2011
Hospira, now a wholly owned subsidiary of Pfizer
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Brief Summary:
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 or disease

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.

Study Type : Observational
Actual Enrollment : 47 participants
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
Study Start Date : June 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All available subjects who received treatment in DURECT protocol C803-017.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01139866

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
Hospira, now a wholly owned subsidiary of Pfizer
Study Director: Dmitri Lissin, MD Durect

Responsible Party: Christina Blevins, Clinical Research Associate, DURECT Corporation Identifier: NCT01139866     History of Changes
Other Study ID Numbers: C803-017e
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: July 15, 2011
Last Verified: July 2011

Keywords provided by Durect:
Long-term Safety
Shoulder Surgery

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents