A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study 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
- 311
- 试验地点
- 233
- 主要终点
- Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
研究概览
简要总结
This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.
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
- Double (Participant, 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
- •Diagnosis of Type 1 or Type 2 diabetes mellitus
- •Meet the per protocol criteria of diabetic gastroparesis
- •Compliance with diary
- •Compliance with the per protocol study treatment dosing instructions
排除标准
- •Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
- •Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of Screening (Visit 1)
- •Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
- •History of gastrointestinal disorders that may be similar to gastroparesis
- •Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
研究组 & 干预措施
Placebo
Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
干预措施: Placebo (Drug)
Relamorelin 10 μg
Following a 2-week placebo run-in, participants received relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 12 weeks.
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)
时间窗: Baseline (Day-14 to Day-1) to Week 12
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.
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-week Treatment Period.
次要结局
- Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period(Baseline (Day-14 to Day-1) to (Week 6 to Week 12))
- Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period(Baseline (Day-14 to Day-1) to (Week 6 to Week 12))
- Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results(Up to 12 weeks)
- Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period(Baseline (Day-14 to Day-1) to (Week 6 to Week 12))
- Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)(Up to approximately 16 weeks)
- Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results(Up to 12 weeks)
- Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period(Baseline (Day-14 to Day-1) to (Week 6 to Week 12))
- Number of Participants With Anti-relamorelin Antibody Testing Results by Visit(Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84))
- Number of Participants With Clinically Meaningful Trends for Vital Signs(Up to 12 weeks)
- Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)(Baseline (Day 1) up to 12 weeks)