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CTRI Number  CTRI/2018/01/011061 [Registered on: 01/01/2018] Trial Registered Prospectively
Last Modified On: 09/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To compare the effectiveness of two types of laxatives namely Polyethylene Glycol 3350 vs. Lactulose for treatment of constipation in Indian Children 
Scientific Title of Study   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. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MC/PEG3350/2017/CT-01 Version 1 Dated, 5 Aug 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Monjori Mitra 
Designation  Research Director 
Affiliation  Medclin Research Pvt. Ltd. 
Address  Medclin Research Pvt. Ltd. Acropolis , Unit No 10/5 , 10th floor 1858/1,Rajdanga Main Road,Kol-107

Kolkata
WEST BENGAL
Kolkata-700107
India 
Phone  9831075734  
Fax    
Email  monjorimr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Monjori Mitra 
Designation  Research Director 
Affiliation  Medclin Research Pvt. Ltd. 
Address  Medclin Research Pvt. Ltd. Acropolis , Unit No 10/5 , 10th floor 1858/1,Rajdanga Main Road,Kol-107

Kolkata
WEST BENGAL
Kolkata-700107
India 
Phone  9831075734  
Fax    
Email  monjorimr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Monjori Mitra 
Designation  Research Director 
Affiliation  Medclin Research Pvt. Ltd. 
Address  Medclin Research Pvt. Ltd. Acropolis , Unit No 10/5 , 10th floor 1858/1,Rajdanga Main Road,Kol-107

Kolkata
WEST BENGAL
Kolkata-700107
India 
Phone  9831075734  
Fax    
Email  monjorimr@gmail.com  
 
Source of Monetary or Material Support  
Fourrts (India) Laboratories Pvt. Ltd. Plot No-1.Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam, Chennai-600097.  
 
Primary Sponsor  
Name  Fourrts India Laboratories Pvt Ltd  
Address  Plot No-1.Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam, Chennai-600097 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Apurba Ghosh  Institute of Child Health  Room No-113 Project room,11, Dr Biresh Guha Street Kolkata 700017
Kolkata
WEST BENGAL 		 9830052887

apurbaghosh@yahoo.com 
DrNirmala Dheivamani  Institute of Child Health,  Halls Road, Egmore, Chennai, Tamil Nadu 600008
Chennai
TAMIL NADU 		 9040151024

nirmalanatarajan89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional ethics committee,ICH-Kolkata  Approved 
Institutional ethics committee.ICH,Chennai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K590||Constipation, Functional constipation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laxopeg  Polyethylene Glycol 3350 - powder 1 sachet to be stirred in 100-200 ml or 8 ounce of water (0.7g–1.5 g/ kg body weight) orally once daily for 4 weeks  
Comparator Agent  Laxoluz  Lactulose suspension - 0.7g -2.0g/kg/body weight) orally once daily for 4 weeks 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
Monitoring of AEs and SAE s and assesment of acceptibility through Likart scale   6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/01/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.

 
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