The Influence of Tramadol on Opioid-induced Bowel Dysfunction (NCT06385561) | Clinical Trial Compass
CompletedPhase 2
The Influence of Tramadol on Opioid-induced Bowel Dysfunction
Denmark20 participantsStarted 2022-08-11
Plain-language summary
Tramadol is a weak opioid and widely used to treat moderate to severe pain. Stronger opioids are known to inhibit gastrointestinal motility and secretion, however the effects of tramadol on gastrointestinal function remains less understood. The aim of this study was to determine to what degree tramadol causes opioid-induced bowel dysfunction by using an objective design to explore gastrointestinal transit, motility pattern, secretion, and colonic volume, in a group of healthy male volunteers.
Who can participate
Age range20 Years – 40 Years
SexMALE
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Inclusion Criteria:
* Healthy (assessed by a study-affiliated medical doctor.)
* Signed informed consent.
* Able to read and understand Danish.
* Male (to avoid influence of menstrual cycles)
* Northern European descent (to minimize genetic variance influences on drug metabolism).
* The researcher believes that the participant understands the study details, is compliant and is expected to complete the study.
* Opioid naïve\* (who have not taken prescription opioid for one week or longer and at least a year have passed since completion of a previous opioid study.)
* Between 20 and 40 years of age.
* A State Trait Anxiety Inventory (STAI) score in the range of 20-37 i.e., classified as "no or low anxiety" at inclusion.
Exclusion Criteria:
* Known hypersensitivity or allergy towards the used pharmaceutical compounds or pharmaceutical compounds similar to those used in the study.
* Less than three spontaneous bowel movements per week.
* Participation in other studies within 14 days prior to first visit.
* Expected need of medical/surgical treatment during the study.
* Any diagnosed 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 complicati…