| CTRI Number |
CTRI/2024/03/063855 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Efficacy & Tolerability Of Polyethylene Glycol 4000 Versus Polyethylene Glycol 3350+ Electrolytes for Treatment of excessive stool loading in Children with Functional Constipation |
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Scientific Title of Study
|
Comparison of Efficacy & Tolerability Of Polyethylene Glycol 4000 Versus Polyethylene Glycol 3350+ Electrolytes For Fecal Disimpaction in Pediatric Functional Constipation: A Double-Blind Randomized Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalpana Panda |
| Designation |
Associate Professor |
| Affiliation |
Institute of Medical Sciences (IMS) and SUM Hospital |
| Address |
Department of Pediatrics
Institute of Medical Sciences (IMS) and SUM Hospital
Bhubaneswar
ODISHA
PIN 751003
Khordha
ORISSA
751003
India |
| Phone |
9717133189 |
| Fax |
|
| Email |
drkalpanapanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Panda |
| Designation |
Associate Professor |
| Affiliation |
Institute of Medical Sciences (IMS) and SUM Hospital |
| Address |
Department of Pediatrics
Institute of Medical Sciences (IMS) and SUM Hospital
Bhubaneswar
ODISHA
PIN 751003
Khordha
ORISSA
751003
India |
| Phone |
9717133189 |
| Fax |
|
| Email |
drkalpanapanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Panda |
| Designation |
Associate Professor |
| Affiliation |
Institute of Medical Sciences (IMS) and SUM Hospital |
| Address |
Department of Pediatrics
Institute of Medical Sciences (IMS) and SUM Hospital
Bhubaneswar
ODISHA
PIN 751003
Khordha
ORISSA
751003
India |
| Phone |
9717133189 |
| Fax |
|
| Email |
drkalpanapanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences (IMS)and SUM Hospital |
|
|
Primary Sponsor
|
| Name |
Institute of Medical sciences (IMS) and SUM Hospitalk |
| Address |
Bhubaneswar, Odisha, PIN 7510003 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr KALPANA PANDA |
Institute of Medical sciences (IMS) and SUM hospital |
Department of Pediatrics, Division of Pediatric Gastroenterology & Hepatology, Room No-4
Khordha
ORISSA |
91-9717133189
drkalpanapanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Medical Sciences (IMS) and SUM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K590||Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Polyethylene glycol (PEG) (3350 +Electrolytes) ARM [PEG 3350+E ARM] |
PEG [33500+Electrolyte] will be administered at a dose of 1.5 gm/kg/day dissolved in water until resolution of fecal impaction or a maximum till 6 days whichever is earlier.
Fecal impaction Resolution is defined as passage of clear liquid stool and no palpable abdominal fecolith |
| Intervention |
Polyethylene glycol (PEG)4000 ARM [PEG 4000 ARM] |
PEG 4000 will be administered at a dose of 1.5 gm/kg/day dissolved in water until resolution of fecal impaction or a maximum till 6 days whichever is earlier.
Fecal impaction Resolution is defined as :
Passage of clear liquid stool and no palpable abdominal fecolith
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1-16 years age admitted to the inpatient department
2. Having h/o functional constipation as per ROME IV criteria
3)with Fecal impaction defined as
A hard mass in the lower abdomen identified on physical examination or
Dilated rectum filled with large amount of stool on per rectal Examination or
Excessive stool in the colon on abdominal radiography as determined by a radiologist
|
|
| ExclusionCriteria |
| Details |
1) Patients with drug-induced constipation
2) Organic constipation ie,
I.Neurological disorders eg. Neural tube defects/cerebral/motor neuron diseases/neuro regression syndromes
II.Hirschsprung disease, or anal anomalies
III.Known metabolic or endocrine disorders
3) Patients with previous gastrointestinal surgery (except appendectomy)
4) Children with suspected gastrointestinal obstruction
5) Patients taking PEG (either at the time of enrolment or within 2 month before enrolment)
6) Patients receiving medication at enrolment or within 1 month before enrolment influencing gastrointestinal motility function (eg, lactulose, loperamide, cisapride)
7) Known history of Allergy to PEG formulations
8) Patients having comorbidity of any other system like CVS/Respiratory/CNS etc
9)Known case of Chronic kidney disease or history of acute kidney injury in past 3 monthes
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The proportion of subjects achieving fecal disimpaction in Each Arm
|
6 days from allocation of treatment or resolution of fecal impaction whichever is earlier
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total no of Days required to achieve fecal disimpaction in each arm |
6 days from treatment allocation/fecal impaction resolution whichever is earlier |
| Cumulative PEG dose required for fecal disimpaction in each arm |
6 days from treatment allocation/fecal impaction resolution whichever is earlier |
| Proportion of subjects reporting palatability issues in each arm |
6 days from treatment allocation/fecal impaction resolution whichever is eariler |
| Proportion of subjects discontinuing the treatment due to palatability issues in each arm |
6 days from treatment allocation/fecal impaction resolution whichever is earlier |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/03/2024 |
| Date of Study Completion (India) |
15/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Childhood constipation is a common but serious gastrointestinal disorder prevalent worldwide. In approximately 90-95% of children, it is of functional origin i.e., without an identifiable organic pathology. Thirty to seventy-five percent of children with functional constipation also have fecal impaction. The treatment strategy for functional constipation includes fecal disimpaction and maintenance therapy to ensure regular bowel movements. ESPGHAN & NASPGHAN guidelines as well as Indian Academy of Pediatrics emphasize that maintenance therapy remains ineffective until disimpaction has been achieved. If initial disimpaction is skipped, oral laxative therapy may paradoxically worsen fecal incontinence/encopresis attributable to overflow diarrhea. Polyethylene glycol (PEG) based laxatives have been recommended as the first-line therapeutic agents for both disimpaction as well as maintenance therapy in childhood functional constipation. The commonly used formulations are PEG 3350 with a molecular weight between 3200 and 3700 g/mol and PEG 4000 with an approximate molecular weight of 4000 g/mol. Both are shown to be effective in pediatric constipation management in placebo-controlled trials. PEG 3350 + Electrolyte (E) is more widely used than PEG 4000 for the management of constipation. This might be because of the perception that PEG 3350 + E is safer in terms of preventing electrolyte imbalance. However, because of the inclusion of electrolytes, PEG 3350+ E solution taste saltier than PEG 4000. Many patients struggle to tolerate the unpleasant taste resulting in the high incidence of non-compliance and treatment failure. To date, no pediatric trials have compared PEG 4000 versus PEG 3350+E on a head-to-head basis for the treatment of the initial but most important & crucial step of pediatric function constipation management i.e. Fecal disimpaction. Therefore, the present study has been planned to evaluate the efficacy & tolerability of PEG 4000 versus PEG 3350+ E for fecal disimpaction in pediatric functional constipation. Patients between age 1-16 years having functional constipation (as per ROME IV criteria) with fecal impaction will be included. Subjects will be randomly assigned to either PEG 4000 or PEG 3350+E at a ratio of 1:1. They will be stratified into 3 different age groups: 1-5 years, 6-11 years, and 12–16 years. They will receive either of the PEG solutions (as per allocation) at a dose of 1.5 gm/kg/day for 6 consecutive days or till the resolution of fecal impaction whichever is earlier. The resolution of fecal impaction is defined as the passage of clear liquid stool and the disappearance of palpable abdominal fecolith. Primary outcome is defined as the proportion of subjects achieving fecal disimpaction in each arm. Secondary outcomes are defined as follows: 1.Total no of Days required to achieve fecal disimpaction in each arm 2.Cumulative dose of PEG required for fecal disimpaction in each arm 3.Proportion of subjects (> 5 years age) reporting palatability issues in each arm 4.Proportion of subjects discontinuing the treatment due to palatability issues in each arm
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