A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 467
- 试验地点
- 332
- 主要终点
- Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period
研究概览
简要总结
A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 are eligible to be included in the study only if all the following criteria apply:
- •Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study
- •Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
- •In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
- •Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
- •Participant has an unresolved adverse event (AE) or 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
研究组 & 干预措施
Treatment Period: Placebo
Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.
干预措施: Placebo (Drug)
Treatment Period: Relamorelin 10 μg
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks.
干预措施: Relamorelin (Drug)
Randomized Withdrawal Period: Placebo then Relamorelin 10 μg
Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.
干预措施: Placebo (Drug)
Randomized Withdrawal Period: Placebo then Relamorelin 10 μg
Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period.
干预措施: Relamorelin (Drug)
Randomized Withdrawal Period: Relamorelin 10 μg then Relamorelin 10 μg
Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period.
干预措施: Relamorelin (Drug)
Randomized Withdrawal Period: Relamorelin 10 μg then Placebo
Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
干预措施: Placebo (Drug)
Randomized Withdrawal Period: Relamorelin 10 μg then Placebo
Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
干预措施: Relamorelin (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period
时间窗: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study
Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
时间窗: Week 6 to Week 12
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period.
次要结局
- Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period(Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12))
- Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period(Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12))
- Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period(Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12))
- Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period(Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12))
- Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period(Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40))
- Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period(Week 37 to Week 40)
- Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period(Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40))
- Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period(Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46))
- Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period(Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46))
- Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)(First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks))
- Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results(Up to 46 weeks)
- Number of Participants With Clinically Meaningful Trends for Vital Signs(Up to 46 weeks)
- Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results(Up to 46 weeks)
- Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)(Up to 46 weeks)
- Number of Participants With Anti-relamorelin Antibody Testing Results(Up to 46 weeks)