Trials Sponsors Conditions Drugs Pricing

Conditions

Opioid-induced constipation

Outcome Measures

Primary Outcomes (1)

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

Lactose monohydrate 320mg tablet, once orally, for 2 study visitsType not reported

NALOXEGOLType not reported

BISACODYLType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
NALOXEGOL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
BISACODYL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SUPPOSITORY
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

NALOXEGOL
Named ingredient: naloxegol
View registry record
BISACODYL
Named ingredient: Bisacodyl
View registry record

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Voluntary written informed consent of the participant or their legally authorized representative has been obtained
Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.

Sponsors & Collaborators

UZ Leuven
Type not reportedlead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Jan Tack+3216345514 jan.tack@kuleuven.be

Central Study Contacts

Jan Tack

+3216345514 jan.tack@kuleuven.be

Study Design

Study Type: interventional
Phase: phase 4

Study Record Dates

First Submitted

June 13, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-512673-28-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 04:54:20 UTC

Documents

Results_MRI study for CTIS

You may not qualify if:

Participant has a history of diverticulitis, intestinal obstruction, stricture, toxic megacolon, GI perforation, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease)
Participant has an unstable renal, hepatic, metabolic, or hematologic condition
Smoking on the day of the investigation and the day prior to it.
Non-removable piercings or metal implants
Known allergy towards the study medication
Participant has any of the following surgical history: a. Any abdominal surgery within the 3 months prior to prescreening; b. History of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy more than 3 months earlier are allowed).
Participant has asthma
Participant has a history of a cardiovascular event, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6 months prior to prescreening
Any other disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial a. current evidence of laxative abuse or history of drug abuse. b. current (within 14 days of randomization) or expected use of any narcotic or opioid containing agents, docusate, enemas, GI preparations (including antacids containing aluminum or magnesium, antidiarrheal agents, antinausea agents, antispasmodic agents, bismuth, or prokinetic agents) (see 5.3 prohibided concomitant medication). c. Intake of drugs that interfere with the GI motility and fluid balance for 1 month prior to the investigation (see 5.3 prohibided concomitant medication). d. Consumption of grapefruit (juice) or medication that interferes with Naloxegol (CYP3A4 inducers/blockers).
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
Participation in an interventional Trial with an investigational medicinal product (IMP) or device within 30 days prior to randomisation, or is currently enrolled in an investigational study
HV has a history of malignancy within 5 years before prescreening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
Subjects known to be ultrarapid metabolizers of CYP2D6

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations