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The influence of tramadol on opioid-induced bowel dysfunction

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500108-23-00
Enrollment
20
Registered
2022-05-31
Start date
2022-08-08
Completion date
2023-05-15
Last updated
2023-02-13

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

Conditions

Opioid induced bowel dysfunction

Brief summary

To evaluate total gastrointestinal transit time (MTS-2), To evaluate colorectal transit time

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 MTS-2), Colon volume (assessed with MRI), Water content in the colon (assessed with MRI), Gastric half emptying time (assessed with MRI), Gastric accommodation (assessed with MRI), Gastric motility (assessed with MRI), Small bowel motility (assessed with MRI), Small bowel water content (assessed with MRI)

Interventions

DRUGTRAMADOL
DRUGPlacebotablet 10mm

Sponsors

Aalborg University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
To evaluate total gastrointestinal transit time (MTS-2), To evaluate colorectal transit time

Secondary

MeasureTime 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 MTS-2), Colon volume (assessed with MRI), Water content in the colon (assessed with MRI), Gastric half emptying time (assessed with MRI), Gastric accommodation (assessed with MRI), Gastric motility (assessed with MRI), Small bowel motility (assessed with MRI), Small bowel water content (assessed with MRI)

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026