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Colonic Motor Patterns in Healthy Volunteers

NCT05770960 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-03-16

No results posted yet for this study

Summary

Characterization of motor patterns with opioid agonists (codeine) ingestion, and their reversal by a peripherally acting mu-opioid receptor antagonist (Naloxegol).

Conditions

  • Opioid-Induced Constipation

Interventions

DRUG

Naloxegol

Oral administration of Naloxegol after waking up from the Midazolam administration during the colonoscopy.

DRUG

codeine phosphate

Oral administration of Codeine after waking up from the Midazolam administration during the colonoscopy.

OTHER

Placebo

Oral administration of siripus simplex syrup after waking up from the Midazolam administration during the colonoscopy.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Jan Tack, Professor · UZ Leuven / KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2019-05-09
Completion
2019-05-09

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05770960 on ClinicalTrials.gov