A new way of evaluating the adverse effects of opioids on the gut.

Phase 1

Conditions: 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: EUCTR2013-001540-60-DK

Lead Sponsor: Mech-Sense, Aalborg University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•Known allergy towards 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.
•History of substance abuse.
•Family history of substance abuse.
•Daily alcohol consumption
•Daily nicotine consumption (e.g. cigarette smoking, nicotine patch, etc.).
•Need to operate motor vehicle within the study periods.
•Metal implants or pacemaker.
•Piercings.
•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: The primary objective is to develop and validate a model capable of assessing gastrointestinal adverse effects of opioid treatment: opioid induced bowel dysfunction (OIBD) in healthy volunteers (substudy 1a and 1b).;Secondary Objective: Secondary objectives include comparing the effect of different treatment regiments on OIBD in healthy volunteers (substudy 2a) and to explore OIBD in patients suffering in ongoing pain management therapy (substudy 2b).;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 5 within all 5-day study periods.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Faecal volume in ascending, transverse, descending colon (MR colonography).<br>•GI metabolomics and microbiomics (stool sample).<br>•Sphincter function (FLIP).<br>•Gut secretion assessed as electrical potential across the gut mucosa (Ussing chambers).<br>•Subjective assessments of adverse effects (questionnaires).<br>;Timepoint(s) of evaluation of this end point: On day 1 and day 5, respectively.