NCT04680156终止不适用
An Observational, Double-blind (Sponsor Open), Long-term Study to Evaluate the Safety and Durability (Efficacy) of Response to EN3835 Compared to Placebo in the Treatment of Adhesive Capsulitis of the Shoulder (Frozen Shoulder)
Endo Pharmaceuticals30 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年12月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 30
- 主要终点
- Change in ASES composite score in affected shoulder
研究概览
简要总结
This is a long-term follow-up study to evaluate the safety and durability (efficacy) of response to EN3835 compared to placebo in participants who were treated in EN3835-210 or the pivotal Phase 3 parent studies for the treatment of AC of the shoulder (frozen shoulder).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Have been enrolled and completed the EN3835-210 or pivotal Phase 3 parent studies (for Study EN3835-223 eligibility, completed participants are those who were assessed for safety and obtained ASES scores at Day 95/EOS Visit; does not include early terminated participants).
- •Be willing not to use pain medications for the duration of the study period and for 2 weeks prior to the Day 180 visit. Pain medications include but are not limited to: barbiturates, benzodiazepines, methadone, buprenorphine, opioids (e.g., codeine, heroin, hydrocodone, hydromorphone, morphine, oxycodone), and cannabis.
- •Note: NSAIDs (ibuprofen, etc.) are allowed.
- •Be willing to undergo MRI of the affected shoulder as required by the protocol.
- •Be able to read, understand, and independently complete patient reported outcome instruments in English.
- •Be willing and able to cooperate with the requirements of the study.
- •Be adequately informed and understand the nature and risks of the study and be able to provide consent.
排除标准
- •Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the IRB/IEC.
- •Plans to receive (or received prior to Day 180) any invasive or minimally invasive (ie, steroid injections, shoulder manipulation, surgery, etc.) procedures to the affected shoulder during study participation.
- •Note: PT is allowed. Any PT received should be captured in the respective electronic case report form (eCRF).
- •Has any contraindications for MRI (implant containing metal, internal metallic object, permanent cosmetics/make-up/tattoos-with exemption of the area to be treated/reviewed, claustrophobia, syncope, low blood pressure, epilepsy, asthma, anemia, or sickle cell disease) as determined by the technologist, the radiologist, and/or investigator performing imaging.
- •Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
研究组 & 干预措施
EN3835
Previously treated with EN3835 in EN3835-210 or the pivotal phase 3 studies
干预措施: Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies (Drug)
Placebo
Previously treated Placebo in EN3835-210 or the pivotal phase 3 studies
干预措施: Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies (Drug)
结局指标
主要结局
Change in ASES composite score in affected shoulder
时间窗: Days 180, 270, and 360
The change from Day 95/end of study (EOS) in the parent studies in the adapted American Shoulder and Elbow Society (ASES) composite score for the affected shoulder
次要结局
未报告次要终点
研究者
研究点 (30)
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