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

A novel approach to assess gastrointestinal adverse effects of opioids

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001540-60-DK

Enrollment

Unknown

Registered

2013-08-01

Start date

2013-08-08

Completion date

Unknown

Last updated

2017-10-02

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

Conditions

Opioid-induced bowel dysfunction. MedDRA version: 18.0 Level: LLT Classification code 10071128 Term: Opioid induced constipation System Organ Class: 100000004856

Interventions

Trade Name: OxyContin Product Name: OxyContin Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: Oxycodone CAS Number: 124-90-3 Other descriptive name: OXYCODONE HYDROCHLORIDE Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

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

Measure

Time frame

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

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Countries

Denmark

Contacts

Public ContactDept. Gastroenterology & Hepatology

Mech-Sense, Aalborg University Hospital

4599326243

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026