Double-blind placebo-controlled cross-over MRI study to evaluate the effect of naloxegol and codeine on gastrointestinal motility and volumes

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512673-28-00

Enrollment

Registered

2024-09-16

Start date

2024-10-28

Completion date

2025-07-03

Last updated

2024-09-16

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

Conditions

Opioid-induced constipation

Brief summary

investigation of the effect of the 3 drug-arms (placebo+placebo, naloxegol+codeine, placebo+codeine) on both colonic motility and segmental colorectal volumes at baseline, after an oat porridge meal and after bisacodyl administration

Interventions

DRUGLactose monohydrate 320mg tablet

DRUGonce orally

DRUGfor 2 study visits

DRUGNALOXEGOL

DRUGBISACODYL

DRUGSirupus simplex 30mL followed by 15mL after two hours

DRUGat one study visit

DRUGBRONCHODINE 10mg/5ml siroop

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
investigation of the effect of the 3 drug-arms (placebo+placebo, naloxegol+codeine, placebo+codeine) on both colonic motility and segmental colorectal volumes at baseline, after an oat porridge meal and after bisacodyl administration	—

Countries

Belgium

Outcome results

None listed

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