Prevention of opioid-induced constipation in patients with advanced cancer.

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509462-38-00

Acronym

08440012010002

Enrollment

250

Registered

2024-10-28

Start date

2022-10-25

Completion date

Unknown

Last updated

2025-07-17

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

Conditions

Patients with advanced cancer.

Brief summary

The primary endpoint is constipation, defined as the percentage of patients with a score of <30 of the Bowel Function Index, measured on day 14.

Detailed description

Change of the Bowel Function Index Score between day 0 and day 14;, Quality of life;, Rome IV criteria for opioid-induced constipation as judged by professional care givers;, Cancer pain score;, Side effects of laxatives;, Cost-effectiveness of macrogol/electrolytes compared to magnesium hydroxide;, Patient satisfaction with laxative.

Interventions

DRUGMagnesiumhydroxide Teva 724 mg

DRUGkauwtabletten

DRUGMovicolon Naturel 13

DRUG7 g

DRUGpoeder voor drank

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is constipation, defined as the percentage of patients with a score of <30 of the Bowel Function Index, measured on day 14.	—

Secondary

Measure	Time frame
Change of the Bowel Function Index Score between day 0 and day 14;, Quality of life;, Rome IV criteria for opioid-induced constipation as judged by professional care givers;, Cancer pain score;, Side effects of laxatives;, Cost-effectiveness of macrogol/electrolytes compared to magnesium hydroxide;, Patient satisfaction with laxative.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026