| CTRI Number |
CTRI/2026/03/106707 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
21/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of polyethylene glycol vs bisacodyl as prophylactic agents for opioid induced constipation in cancer patient |
|
Scientific Title of Study
|
comparative efficacy of Polyethylene glycol and Bisacodyl as prophylactic agents for opioid induced constipation in cancer patients initiated on morphine therapy |
| 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 Sanjay Meena |
| Designation |
junior resident |
| Affiliation |
Dr B.R.A.I.R.C.H. AIIMS, NEW DELHI |
| Address |
ROOM NO. 60, Dr B.R.A.I.R.C.H. AIIMS, NEW DELHI, ANSARI NAGAR
South West
DELHI
110029
India |
| Phone |
9602455670 |
| Fax |
|
| Email |
sanjay.meena541996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishkarsh gupta |
| Designation |
professor |
| Affiliation |
Dr B.R.A.I.R.C.H. AIIMS, NEW DELHI |
| Address |
Dr B.R.A.I.R.C.H. AIIMS, NEW DELHI, ANSARI NAGAR
South West
DELHI
110029
India |
| Phone |
9602455670 |
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Meena |
| Designation |
junior resident |
| Affiliation |
Dr B.R.A.I.R.C.H. AIIMS, NEW DELHI |
| Address |
ROOM NO. 60, Dr B.R.A.I.R.C.H. AIIMS, NEW DELHI, ANSARI NAGAR
South West
DELHI
110029
India |
| Phone |
9602455670 |
| Fax |
|
| Email |
sanjay.meena541996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Onco-Anesthesia and Palliative Medicine, Dr.B.R.Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, New Delhi pin-110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
Ansari Nagar, New Delhi pin-110029 India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Meena |
All India Institute of Medical Sciences |
ROOM NO. 60, Dr B.R.A.I.R.C.H. AIIMS, NEW DELHI, ANSARI NAGAR
South West
DELHI |
9602455670
sanjay.meena541996@gmail.com |
| Dr Sanjay Meena |
National Cancer Institute |
Palliative Medicine OPD- Department of Onco-Anesthesia and Palliative Medicine, First Floor, OPD building, National Cancer Institute, Badsa, Jhajjar PIN-124105
Jhajjar
HARYANA |
9602455670
sanjay.meena541996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee- All India Institute of Medical Science, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
drug for constipation
bisacodyl |
Bisacodyl 10mg
2 tablets per orally
once daily bedtime
for 1 month |
| Intervention |
drug for constipation
polyethylene glycol |
polyethylene glycol syrup
per orally
15ml
bed time
for 1 month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All cancer patient whose performance status is more than 70%,life expectancy more than 12 week and plan to initiated on morphine therapy.
All patient who can understand Hindi/English. |
|
| ExclusionCriteria |
| Details |
1. Age below 18 years.
2. patient with a known history of gastrointestinal obstruction or perforation.
3. presence of non opioid related causes of constipation(eg. hypothyroidism, neurological disorders).
4. Patients with renal or hepatic failure affecting drug metabolism or excretion.
5.Known hypersensitivity to Polyethylene glycol or Bisacodyl.
6. pregnant or lactating women.
7. Those expected to start/stop any treatments which might impact bowel function other than opioids throughout the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of polyethylene glycol and bisacodyl in preventing opioid induced constipation in cancer patients initiating morphine therapy. The primary endpoint is the incidence of opioid induced constipation, as assessed by revised victoria bowel performance scale. |
at baseline, day 15, day 30, 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of adverse effects (eg. cramping, bloating, electrolyte imbalance) associated with polyethylene glycol & bisacodyl use. |
day 15, day 30 & at 3 month |
| To assess the impact of treatment on quality of life, including any modifications in opioid use due to constipation-related discomfort. |
day 15, day 30 & at 3 month |
|
|
Target Sample Size
|
Total Sample Size="253"
Sample Size from India="253"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Despite the availability of multiple treatment options, theres is a pressing need for well designed clinical studies that directly compare the efficacy and safety of these therapies, especially in cancer patient receiving opioid. the present study is designed to compare polyethylene glycol and bisacodyl in preventing opioid induced constipation in cancer patients initiating morphine for cancer related pain by assessing metrics like stool frequency, stool form, patient satisfaction and any treatment related side effects. A total of 253 patients visiting palliative medicine OPD will be recruited for the study as per the inclusion and exclusion criteria. online software based block randomization will be done to allot patients into two groups. group A will receive polyethylene glycol and group will get bisacodyl. patients will be assessed at baseline and then followed up at day 15, day 30 and day 90th post intervention. The findings of this investigation aim to aid clinicians in making informed treatment choices and improving outcomes of patients suffering from this challenging condition. |