NCT01642550已完成2 期
A Phase 2, Investigator-Initiated, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa
Motus Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effect of RM-131 on body weight
研究概览
简要总结
The purpose of this study is to determine if administration of RM-131 is effective in improving appetite and gastrointestinal symptoms leading to the recovery of patients with anorexia nervosa in the outpatient setting.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DSM-IV criteria for anorexia nervosa, including weight <85% of ideal body weight (IBW) and amenorrhea for three months;
- •Age 18-45 years old;
- •Gastrointestinal tract symptoms;
- •Non-hormonal method of birth control, which must be used throughout the study. Female patients unable to bear children must have this documented (i.e., tubal ligation, hysterectomy, or post-menopausal, defined as a minimum of one year since the last menstrual period and elevated FSH);
- •Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to baseline;
- •Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures, including daily SC injections and completion of a daily injection log.
- •Patient has a primary care physician or treatment team managing her care.
排除标准
- •Use of hormone therapy (including but not limited to estrogen, progesterone) or hormonal methods of birth control (i.e., oral, implantable, or injectable) within eight weeks of screening; or Depo-Provera within six months of screening;
- •Pregnancy, lactation or breastfeeding, or a positive serum or urine pregnancy test, within eight weeks of screening;
- •History of diabetes mellitus;
- •History of purging behaviors greater than once monthly within the last three months;
- •Active substance abuse;
- •Use of metoclopramide, erythromycin, 5HT3 anti-emetics, or opioid medications within 2 weeks prior to baseline. [Note: these drugs should also not be used post-baseline];
- •Hematocrit < 30.0 %, hemoglobin < 10.0 g/dl, potassium < 3.0 mmol/L, fasting glucose > 100 mg/dL, creatinine > 1.5 mg/dL, AST or ALT > 1.5 times the upper limit of normal, or abnormal plasma thyroid stimulating hormone (TSH) level;
- •Currently receiving parenteral feeding or enteral feeding, or presence of a nasogastric or other enteral tube for feeding or decompression;
- •History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure, small or large bowel resection;
- •Clinical suspicion, in the opinion of the investigator, of active or symptomatic peptic ulcer disease, cholelithiasis, colitis, celiac sprue, or inflammatory bowel disease;
- •Active suicidal ideation;
- •Beck Depression Inventory-2 score of ≥ 29;
- •Current inpatient hospitalization;
- •Allergic or intolerant of egg, milk, wheat or algae, as these are components of the GEBT test meal;
- •Participation in a clinical study with an investigational medication or device within the 30 days prior to dosing in the present study;
- •Any other reason, which in the opinion of the Investigator, including severe renal, hepatic or cardiac disease, would confound proper interpretation of the study or expose a patient to unacceptable risk.
研究组 & 干预措施
RM-131
Active Comparator
Active study drug - RM-131
干预措施: RM-131 (Drug)
Placebo
Placebo Comparator
Placebo comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of RM-131 on body weight
时间窗: Baseline and Day 28
Change from baseline in body weight.
次要结局
- Effect of RM-131 on appetite(Baseline and Day 28)
- Effect of RM-131 on gastric emptying time(Baseline and Day 28)
研究者
研究点 (1)
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