Nortriptyline for Idiopathic Gastroparesis: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial (NORIG)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 7
- 主要终点
- Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits
研究概览
简要总结
The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 through 65 years old at registration
- •Documentation of delayed gastric emptying on gastric emptying scintigraphy within 2 years of registration, defined as greater than 60% retention at 2 hours or greater than 10% retention at 4 hours
- •Symptoms of gastroparesis for at least 6 months (does not have to be contiguous) prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of 21 or greater
- •Negative upper endoscopy or upper GI series within 2 years of registration
排除标准
- •Normal gastric emptying confirmed with scintigraphy
- •Diabetic gastroparesis or post-surgical gastroparesis including fundoplication
- •Another active disorder which could explain symptoms in the opinion of the investigator
- •History of significant cardiac arrhythmias and/or prolonged QTc
- •History of seizures
- •Use of narcotics more than 3 days per week
- •Use of tricyclic antidepressants for refractory symptoms of gastroparesis within 6 weeks prior to randomization
- •Use of strongly anticholinergic medications
- •Use of calcium channel blockers
- •Use of erythromycin
- •Clear history of failed trial of nortriptyline use for gastroparetic symptoms
- •Symptoms of primary depression or suicidal ideation
- •Contraindications to nortriptyline:
- •hypersensitivity or allergy to any tricyclic antidepressant drug
- •concomitant therapy with a monoamine oxidase inhibitor (MAOI)
- •recent myocardial infarction
- •Pregnancy or nursing
- •Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study
- •Use of a G tube, J tube,or a central catheter for nutrition
- •Use of a gastric electrical stimulator
- •Failure to give informed consent
研究组 & 干预措施
Nortriptyline
Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg
干预措施: Nortriptyline Hydrochloride (Drug)
Placebo (for nortriptyline)
No treatment
干预措施: Placebo (for nortriptyline) (Drug)
结局指标
主要结局
Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits
时间窗: at end of treatment, 15 weeks from baseline assessment
A decrease from the baseline Gastroparesis Cardinal Symptom Index (GCSI) score (sum of the 9 individual symptom scores) of at least 50% on any two consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. The total score ranges from 0-45 with higher scores indicating greater symptom severity.
次要结局
未报告次要终点