Multicentric Phase IV randomized open label controlled trial to assess effectiveness, safety and acceptability of Polyethylene Glycol 3350 versus Lactulose for treatment of functional constipation in children aged 2 years to 12 years.

Fourrts India Laboratories Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Subjects aged 2 to 12 years of either sex presenting to the outpatient department of the hospital with a clinical diagnosis of functional constipation and fecal incontinence according to the Rome IV criteria, at least 2 of the following:
•1. 2 or fewer defecations /week.
•2. History of excessive stool retention
•3. History of painful or hard bowel movements.
•4. Presence of a large faecal mass in the rectum
•5. History of a large diameter stool
•2.Parent of the subjects must give written informed consent for study participation.
•3.Parent of the subjects must be willing to maintain subject diary and follow all instructions as per the study protocol.
•4.If patient has already consumed any laxative for the current episode, then a wash-out period of about 2 weeks to be given before administering study medication.

•1.Subjects with intestinal pseudo obstruction.
•2.Subjects who are debilitated or seriously ill or immunocompromised.
•3.Subjects with coexisting features of acute systemic disease like septicemia, meningitis, pneumonia etc.
•4.Patients with symptoms or suspicion of an organic lesion of the digestive tract, or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis, Crohnâ??s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose).
•5.Subjects with hypersensitivity to any ingredient in the formulation.
•6.Subjects with history of surgery involving the colon or anus.
•7.Participation in any clinical trial in the last 3 months prior to screening.
•8.Presence of any other medical or surgical condition which as per the judgment of the principal investigator is not conducive for trial participation.

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