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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06385561
Other study ID # Tramadol_OIBD
Secondary ID 2022-500108-23-0
Status Completed
Phase Phase 2
First received
Last updated
Start date August 11, 2022
Est. completion date May 15, 2023

Study information

Verified date April 2024
Source Aalborg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Intervention

Drug:
Tramadol
Tramadol is administered orally twice daily in a dosage of 100 mg (daily total of 200 mg)
Placebo
Placebo is administered orally twice daily.

Locations

Country Name City State
Denmark Aalborg University Hospital Aalborg

Sponsors (1)

Lead Sponsor Collaborator
Asbjørn Mohr Drewes

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total gastrointestinal transit time Difference in hours from ingestion of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment From day 4 to day 8
Primary Colorectal transit time Difference in hours from the entering in the colon of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment From day 4 to day 8
Secondary Constipation symptoms Measured on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire (ranging from 0 (symptom absent) to 4 (very severe). From day 1 to day 10
Secondary Bowel movement frequency Number of spontaneous bowel movements per day From day 1 to day 10
Secondary Stool consistency Rated on the Bristol Stool Form Scale (ranging from type 1 (constipation) - type 7 (diarrhea)) From day 1 to day 10
Secondary Gastrointestinal symptoms Measured on the Gastrointestinal Symptom Rating Score (GSRS) questionnaire (ranging from 0 (no discomfort) to 6 (very severe discomfort) Day 1 and day 10
Secondary Opioid-induced constipation Measured by the Bowel Function Index (BFI) questionnaire (ranging from 0 (not at all) to 100 (very strong). Day 1 and day 10
Secondary Diagnostic evaluation of opioid-induced constipation Assessed using the Rome IV C6 criteria consisting of 7 items rated as either true or false. 2 or more items rated as "true" indicates functional constipation Day 10
Secondary Colonic motility patterns Number of motility patterns in the colon measured by the 3D Transit Capsule From day 4 to day 8
Secondary Opiate withdrawal symptoms Measured by the Subjective Opiate Withdrawal Scale (ranging from 0 (not at all) to 4 /extremely) Day 13, 14 or 15
Secondary Colon volume Volumetric quantification of the colon measured using T2-weighted MRI images Day 10
Secondary Colonic water content Analysis of colonic water content measured using heavily T2-weighted MRI images Day 10
Secondary Gastric half emptying time Analysis of gastric half emptying time after ingestion of a standardized meal measured by MRI Day 1 and day 10
Secondary Gastric contraction assessment Analysis of gastric contraction amplitude after ingestion of a standardized meal measured by MRI Day 1 and day 10
Secondary Gastric contraction assessment Analysis of gastric contraction frequency after ingestion of a standardized meal measured by MRI Day 1 and day 10
Secondary Small bowel motility assessment Analysis of small bowel motility after ingestion of a standardized meal measured using dynamic MRI images. A semi-automated analysis software enables registration of small bowel motility with the calculation of regional motility maps and quantification of motility indices. Day 1 and day 10
Secondary Small bowel water content Analysis of small bowel water content measured using heavily T2-weighted MRI images Day 1 and day 10
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