NCT01280344已完成2 期
Phase II Double-Blind Placebo-Controlled Dose Finding Study to Evaluate Safety/Efficacy of Ipamorelin Compared to Placebo for Recovery of Gastrointestinal Function in Patients Following Small or Large Bowel Resection w/Primary Anastomosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 320
- 主要终点
- Recovery of Gastrointestinal (GI) Function
研究概览
简要总结
Post-operative administration of ipamorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial small and/or large bowel resection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form
- •Males or females, 18 to 85 years of age inclusive at the time of study screening
- •American Society of Anesthesiologists (ASA) Class I-III
- •Have undergone a scheduled small and/or large open partial bowel resection based on a documented incision size greater than or equal to (≥) 10 cm with primary anastomosis
- •Females must not be pregnant as confirmed by a serum pregnancy test at screening and by a urine pregnancy test on the day of surgery
- •Body weight must be between 40-150 kilograms (kg)
排除标准
- •Any procedure which requires a diverting stoma
- •Primary anastomosis not performed at the time of surgery
- •Epidural or intrathecal anesthesia
- •Significant liver disease (ALT and/or total bilirubin > 2-fold upper limits of normal) or kidney disease (serum creatinine > 2.5 mg/dL) at screening
- •History of irritable bowel syndrome
- •Patients with a history of Crohn's disease or ulcerative colitis (UC) who have had multiple GI-related surgeries (Note: surgery naïve Crohn's or UC patients may be included)
- •History of colonic volvulus
- •History of gastroesophageal surgery, gastrectomy, gastric bypass, total colectomy, short bowel syndrome, or multiple complex abdominal surgeries performed by an open procedure (uncomplicated cesarean section and appendectomy would not be considered complex)
- •Patients who have received prior abdominal radiation and/or pelvic radiation
研究组 & 干预措施
0.03 mg/kg BID
Experimental
Ipamorelin 0.03 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)
干预措施: Ipamorelin (Drug)
0.06 mg/kg BID
Experimental
Ipamorelin 0.06 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion)
干预措施: Ipamorelin (Drug)
0.06 mg/kg TID
Experimental
Ipamorelin 0.06 mg/kg, TID (3 investigational drug infusions)
干预措施: Ipamorelin (Drug)
Placebo
Placebo Comparator
Matching placebo, TID (3 placebo infusions)
干预措施: Saline Solution for Injection (Drug)
结局指标
主要结局
Recovery of Gastrointestinal (GI) Function
时间窗: Up to 10 days
To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo
次要结局
- Ancillary GI Functions(Up to 10 days or until hospital discharge)
- Number of Subjects with Adverse Events as a Measure of Safety and Tolerability(14 day outpatient follow-up visit)
研究者
相似试验
已完成
3 期
Ulimorelin Study of Efficacy and Safety (ULISES 007)Gastrointestinal DysmotilityNCT01285570Tranzyme, Inc.332
已完成
3 期
Ulimorelin Study of Efficacy and Safety (ULISES 008)Gastrointestinal DysmotilityNCT01296620Tranzyme, Inc.330
已完成
2 期
Safety and Efficacy of Ipamorelin for Management of Post-Operative IleusIleusNCT00672074Helsinn Therapeutics (U.S.), Inc117
已完成
4 期
A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical CystectomyPostoperative IleusNCT00708201Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)280
已完成
3 期
Prucalopride in Postoperative IleusPostoperative IleusColorectal SurgeryPostoperative ComplicationsNCT02947269University of Auckland, New Zealand150