Opioid induced bowel dysfunction
Conditions
Brief summary
• Total GI transit time (MTS-2), • Colorectal transit time (MTS-2)
Detailed description
• Subjective assessments of constipation (PAC-SYM, BSFS, GSRS, BFI), • Diagnostic evaluation of opioid-induced constipation (Rome IV C6), • Subjective assessment of opiate withdrawal (SOWS), • Segmental transit time of the stomach, small intestine, and colonic segments (assessed with MTS-2), • Detailed colonic motility (assessed with 3D-Transit), • Colon volume (assessed with MRI), • Water content in the colon (assessed with MRI), • Rear-front pressures and defecation indices (measured by Fecobionics)
Interventions
DRUGTramadol HCl Retard Mylan 100 mg
DRUGMatching filmcoated placebo tablets will be provided by Shionogi
DRUGRizmoic 200 micrograms film-coated tablets
Sponsors
Aalborg University Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Total GI transit time (MTS-2), • Colorectal transit time (MTS-2) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Subjective assessments of constipation (PAC-SYM, BSFS, GSRS, BFI), • Diagnostic evaluation of opioid-induced constipation (Rome IV C6), • Subjective assessment of opiate withdrawal (SOWS), • Segmental transit time of the stomach, small intestine, and colonic segments (assessed with MTS-2), • Detailed colonic motility (assessed with 3D-Transit), • Colon volume (assessed with MRI), • Water content in the colon (assessed with MRI), • Rear-front pressures and defecation indices (measured by Fecobionics) | — |
Countries
Denmark
Outcome results
None listed