Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 202
- 试验地点
- 483
- 主要终点
- Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Successful completion of either Study RLM-MD-03 or Study RLM-MD-04
- •Ability to provide written informed consent (IC) prior to any study procedures and willingness and ability to comply with study procedures
- •Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator.
排除标准
- •Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020
- •Participant has an unresolved adverse event (AE) from a lead-in study, ie, a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
- •Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic, or cardiopulmonary disease
- •Females who are pregnant, nursing, or planning a pregnancy during the study.
研究组 & 干预措施
Relamorelin 10 μg
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months.
干预措施: Relamorelin 10 μg (Drug)
结局指标
主要结局
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to approximately 22 months
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
时间窗: Baseline (Day 1) up to approximately 22 months
Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results
时间窗: Up to approximately 22 months
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Number of Participants With Clinically Meaningful Trends for Vital Signs
时间窗: Up to approximately 22 months
Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.
次要结局
未报告次要终点