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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-500108-23-00 | EU Trial (CTIS) Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Active Comparator | Tramadol |
|
| Placebo treatment | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol | Drug | Tramadol is administered orally twice daily in a dosage of 100 mg (daily total of 200 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Bowel movement frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9000 | Denmark |
Data can be provided upon request
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| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Placebo | Drug | Placebo is administered orally twice daily. |
|
Number of spontaneous bowel movements per day
| From day 1 to day 10 |
| Stool consistency | Rated on the Bristol Stool Form Scale (ranging from type 1 (constipation) - type 7 (diarrhea)) | From day 1 to day 10 |
| 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 |
| 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 |
| 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 |
| Colonic motility patterns | Number of motility patterns in the colon measured by the 3D Transit Capsule | From day 4 to day 8 |
| Opiate withdrawal symptoms | Measured by the Subjective Opiate Withdrawal Scale (ranging from 0 (not at all) to 4 /extremely) | Day 13, 14 or 15 |
| Colon volume | Volumetric quantification of the colon measured using T2-weighted MRI images | Day 10 |
| Colonic water content | Analysis of colonic water content measured using heavily T2-weighted MRI images | Day 10 |
| Gastric half emptying time | Analysis of gastric half emptying time after ingestion of a standardized meal measured by MRI | Day 1 and day 10 |
| Gastric contraction assessment | Analysis of gastric contraction amplitude after ingestion of a standardized meal measured by MRI | Day 1 and day 10 |
| Gastric contraction assessment | Analysis of gastric contraction frequency after ingestion of a standardized meal measured by MRI | Day 1 and day 10 |
| 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 |
| Small bowel water content | Analysis of small bowel water content measured using heavily T2-weighted MRI images | Day 1 and day 10 |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |