aloxegol and assessments of opioid induced bowel dysfunctio

Phase 1

• Conditions: Healthy volunteers (Opioid-induced bowel dysfunction); MedDRA version: 18.0Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 100000004856; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2015-000419-42-DK
• Lead Sponsor: Aalborg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-23
• Study Completion: 2016-05-18
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

•Signed informed consent.
•Able to read and understand Danish.
•Male of Northern European descent (in order to minimize genetic variance in the study population).
•The researcher believes that the subject understands the study details, is compliant and is expected to complete the study.
•Opioid naïve
•Between 20 and 60 years of age.
•Healthy.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Known hypersensitivity or allergy towards the pharmaceutical compounds used in the study or pharmaceutical compounds similar to those used in the study.
•Participation in other studies within 14 days prior to first visit.
•Expected need of medical/surgical treatment during the course of the study.
•Any disease, which investigator concludes will affect the trial (including all contraindicated complications: severe chronic obstructive pulmonary disease, pulmonary heart disease, severe bronchial asthma, paralytic ileus, hypercapnia, serious respiratory depression with hypoxia, moderate to severe decreased liver function, gastrointestinal obstruction or perforation, acute surgical abdominal complications such as appendicitis, Mb. Crohn’s, ulcerative colitis, and toxic mega colon).
•History of substance abuse.
•Family history of substance abuse.
•Daily alcohol consumption
•Daily nicotine consumption (e.g. cigarette smoking, nicotine patch, etc.).
•Consumption of grapefruit juice or juice from Seville oranges.
•Need to operate motor vehicle within the study periods.
•Metal implants or pacemaker.
•Use of prescription medicine and/or herbal medicine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect on naloxegol on opioid induced bowel dysfunction (OIBD) using a compressive, objective design to explore motility, secretion and sphincter function;Secondary Objective: Not applicable;Primary end point(s): Gastric emptying, small intestinal, and colorectal transit time (MTS-2).;Timepoint(s) of evaluation of this end point: Continuous measuring from day 1 to day 6, in the total 6-day study period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Subjective assessments of adverse effects (questionnaires).<br>•Faecal volume in ascending, transverse, descending colon (MR colonography).<br>•Gut motility index (MR small intestine)<br>•Sphincter function (FLIP).<br>;Timepoint(s) of evaluation of this end point: •Subjective assessments of adverse effects (questionnaires): Day 1 to day 6, each day in the total 6 day-study period <br>•Faecal volume in ascending, transverse, descending colon (MR colonography): Day 1, day 2, and day 6<br>•Gut motility index (MR small intestine): Day 1, day 2, and day 6<br>•Sphincter function (FLIP): Day 1 and day 6<br>