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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Durect
- 入组人数
- 47
- 主要终点
- 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
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Participants who participated in any other trial with an investigational drug or device since their participation in DURECT protocol C803-017.
结局指标
主要结局
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
时间窗: 18 months post-dose in C803-017 trial
次要结局
未报告次要终点