To compare the effectiveness of two types of laxatives namely Polyethylene Glycol 3350 vs. Lactulose for treatment of constipation in Indian Children
- Conditions
- Constipation, Functional constipation,
- Registration Number
- CTRI/2018/01/011061
- Lead Sponsor
- Fourrts India Laboratories Pvt Ltd
- Brief Summary
Title: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.
Over the past several decades a number of randomized clinical trials have been conducted which have demonstrated a superior effectiveness and tolerability of Polyethylene Glycol 3350 in comparison to lactulose for the management of functional constipation and fecal impaction in children.
There has been no study in India to evaluate the effectiveness of Polyethylene Glycol 3350 in functional constipation based on ROME IV criteria. Hence the present study aims at establishing this effectiveness, safety and acceptability profile of the test formulation Polyethylene Glycol 3350 versus lactulose in children.
The objective of this study is to compare the effectiveness, safety and acceptability of Polyethylene Glycol 3350 in a four weeks treatment period for the treatment of functional constipation in children of age 2-12 years when compared to Lactulose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 100
- 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.
- History of excessive stool retention 3.
- History of painful or hard bowel movements.
- 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, Crohn’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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PEG 3350 vs Lactulose in children with functional constipation , to assess the weekly changes in frequency of stool passed and no. of painful bowel movement per week 6 months
- Secondary Outcome Measures
Name Time Method Monitoring of AEs and SAE s and assesment of acceptibility through Likart scale 6 months
Trial Locations
- Locations (2)
Institute of Child Health
🇮🇳Kolkata, WEST BENGAL, India
Institute of Child Health,
🇮🇳Chennai, TAMIL NADU, India
Institute of Child Health🇮🇳Kolkata, WEST BENGAL, IndiaDr Apurba GhoshPrincipal investigator9830052887apurbaghosh@yahoo.com