Lubiprostone for the Treatment of Functional Constipation in the Under 18 Years Patients: A Randomized, Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 2
- 主要终点
- Primary outcome
研究概览
简要总结
The investigators will enroll subjects 8 - < 18 years of age, fulfilling Rome IV criteria for functional constipation.
Participants will be randomly assigned to either Lubiprostone treatment (study group), or the control group (will receive either lactulose or Bisacodyl tablets).
safety and efficacy will be assessed.
详细描述
The investigators will enroll 274 subjects who will be randomly divided equally into interventional and control groups.
Participants and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and a large volume of fluid.
The control group will receive lactulose 1 mL/kg, once or twice daily (maximum 60 mL/day or Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years.
Both arms will receive the treatment for 12 weeks followed by 4 weeks follow-up after the end of treatment (week 16).
Participants (and their guardians) will be instructed to regularly document the number of spontaneous bowel motions/week and to define their Bristol chart category for every bowel motion. In addition, the participants will be encouraged to contact the trial team if any adverse events appeared. This is in addition to regular visits at 0, 2, 8, 12 weeks for assessment of safety (efficacy will be assessed at weeks 8, 12, and 16).
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
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 8 - < 18 years of age who have a confirmed diagnosis of Pediatric functional constipation according to the Rome IV criteria, who give written informed consent personally or from their legal guardians.
- •Discontinuation of any medication affecting gastrointestinal (GI) motility at least 2 weeks before starting the treatment allocation.
- •Patient's daily diary that indicates an average of < 3 weekly spontaneous bowel movements (SBMs), with ≥ 25% of SBMs involving at least some straining and/or a 5-point modified Bristol Stool Form Scale type 1 or
- •Patients who completed the study protocol.
排除标准
- •If the patient's constipation is attributed to any of the following: physical, mental, or cognitive illness, inflammatory bowel disease, medication, anatomical, neurological, endocrine, or metabolic factors.
- •If the patient is a candidate for or underwent abdominal surgery, or has any condition other than constipation that could affect gastrointestinal motility or defecation.
- •Patients suffering from Hirschsprung's disease.
- •Patients experiencing any alarming signs e.g. unexplained significant weight loss.
- •Untreated fecal impaction at the time of enrollment.
研究组 & 干预措施
Investigational Arm
- Patients will receive lubiprostone capsules (Amiprostone 8 and 24 mcg, or Lubicont 8 mcg)
- Patients weighing <50 kg will be given lubiprostone at doses of 8 mcg/8 hours.
- Patients weighing ≥ 50 kg will be given lubiprostone at doses of 24 mcg BID.
- Patients and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and a large volume of fluid.
干预措施: Lubiprostone Pill (Drug)
Control Arm
Subjects will receive the conventional therapy (one or a combination of the following):
- Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day),
- Bisacodyl tablets " Bisacodyl 5 mg/tablet" in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years, or
- Sodium Picosulfate 0.75% drops (Picolax drops) in a daily dose of 2.5-20 mg/day.
干预措施: Lactulose Oral Liquid Product (Drug)
Control Arm
Subjects will receive the conventional therapy (one or a combination of the following):
- Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day),
- Bisacodyl tablets " Bisacodyl 5 mg/tablet" in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years, or
- Sodium Picosulfate 0.75% drops (Picolax drops) in a daily dose of 2.5-20 mg/day.
干预措施: Bisacodyl 5 MG (Drug)
Control Arm
Subjects will receive the conventional therapy (one or a combination of the following):
- Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day),
- Bisacodyl tablets " Bisacodyl 5 mg/tablet" in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years, or
- Sodium Picosulfate 0.75% drops (Picolax drops) in a daily dose of 2.5-20 mg/day.
干预措施: Sodium Picosulfate (Drug)
结局指标
主要结局
Primary outcome
时间窗: At study week 16.
Spontaneous bowel motions (SBM) ≥ 1 SBM/week increase in the frequency compared with baseline, and ≥ 3 SBMs/week for at least 8 weeks, including the last 4 study weeks and the 4 weeks of follow-up.
次要结局
- First dose response time(1st week of treatment)
- Early spontaneous bowel motions(First 48 hours after first drug dose.)
- Number of Spontaneous Bowel Motions/Week.(At study week Week 8, 12.)
- Responders rate(At study week Week 8, 12, 16.)
研究者
Sameh A. Lashen
Associate Professor of Internal Medicine
Alexandria University