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NCT01139866 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01139866
Other study ID # C803-017e
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2010
Est. completion date April 2011

Study information
Verified date June 2022
Source Durect
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Durect Hospira, now a wholly owned subsidiary of Pfizer, Nycomed

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 18 months post-dose in C803-017 trial
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