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Efficacy of polyethylene glycol vs bisacodyl as prophylactic agents for opioid induced constipation in cancer patient

comparative efficacy of Polyethylene glycol and Bisacodyl as prophylactic agents for opioid induced constipation in cancer patients initiated on morphine therapy - nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106707
Enrollment
253
Registered
2026-03-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: drug for constipation polyethylene glycol: polyethylene glycol syrup per orally 15ml bed time for 1 month. Control Intervention1: drug for constipation bisacodyl: Bisacodyl 10mg 2 tabl

Sponsors

All India Institute of Medical Sciences, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: at baseline, day 15, day 30, 3 month

Secondary

MeasureTime frame
To compare the incidence of adverse effects (eg. cramping, bloating, electrolyte imbalance) associated with polyethylene glycol & bisacodyl use.Timepoint: 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.Timepoint: day 15, day 30 & at 3 month

Countries

India

Contacts

Public ContactDr Sanjay Meena

Dr B.R.A.I.R.C.H. AIIMS, NEW DELHI

drnishkarsh@rediffmail.com9602455670

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026