Clinical trial NCT01139866: An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Long-term Safety
Shoulder Surgery
bupivacaine
Lead sponsor: Durect
Sponsor class: INDUSTRY
Collaborators: name: Nycomed
name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2010-06-09
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All available subjects who received treatment in DURECT protocol C803-017.

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).

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 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.

Primary outcomes:
measure: 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
timeFrame: 18 months post-dose in C803-017 trial
Secondary outcomes:
Other outcomes:
Locations:
city: Westmead
country: Australia
state: New South Wales
city: Auchenflower
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Toorak Gardens
country: Australia
state: South Australia
city: Geelong
country: Australia
state: Victoria
city: Ringwood East
country: Australia
state: Victoria
city: Christchurch
country: New Zealand
city: Hamilton
country: New Zealand
Study officials:
affiliation: Durect
name: Dmitri Lissin, MD
role: STUDY_DIRECTOR
References: