Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Success From Day 10 to Day 13
研究概览
简要总结
To evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel obstruction in patients with peritoneal carcinomatosis
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
- •Patients with symptoms and signs of inoperable bowel obstruction confirmed by a surgeon or clinic and radiographic assessment (CT scan or at least abdominal X-ray);
- •Confirmed peritoneal carcinomatosis (with one of the following criteria : surgery, imaging and/or cytology);
- •No corticotherapy at dose more than 1mg/kg equivalent-methylprednisolone, in the previous 2 weeks ;
- •No chemotherapy in the previous week;
- •No radio or chemotherapy planned at the inclusion and within the two weeks following inclusion
- •Authorized concomitant treatments for local standard medical care : antiemetics, antispasmodics, anti-Histamine2 (H2) drugs blockers or proton pump inhibitor, analgesics; nasogastric tube
排除标准
- •Abnormal coagulation (prothrombin time < 60%, platelets < 50x10^9/L).
- •Non authorized concomitant treatments :
- •Anticholinergics such as scopolamine
- •Other somatostatin analogues
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Octreotide
Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
干预措施: Octreotide LAR (Drug)
Octreotide
Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
干预措施: Octreotide (Immediate release) (Drug)
Octreotide
Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
干预措施: methylprednisolone (Drug)
Placebo
Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
干预措施: Placebo (Drug)
Placebo
Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
干预措施: methylprednisolone (Drug)
结局指标
主要结局
Number of Participants With Treatment Success From Day 10 to Day 13
时间窗: Day 10 to Day 13
Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 \[from Day 10 to Day 13\] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14. Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause.
次要结局
- Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7(Day 7)
- Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14(Day 14)
- Number of Participants With Relief From Obstruction at Day 7 and Day 14(Day 7 and Day 14)
- Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1(1 Month)
- Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2(Month 2)
- Number of Participants With Treatment Success From Day 5 to Day 7(Day 5 to Day 7)
- Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14(Day 1, Day 7 and Day 14)
- Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1(Day 1)
- Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3(Month 3)
- Participant's Quality of Life Using the Edmonton Scale(Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3)