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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507744-36-00 | EU Trial (CTIS) Number |
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Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have the potential to block the effects of opioids in the gastrointestinal tract while preserving the central analgesic effect. In this study, we will investigated the effects of Naldemedine in preventing the development of opioid-induced bowel dysfunction and constipation during treatment with tramadol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Active Comparator | Naldemedine + tramadol |
|
| Placebo treatment | Placebo Comparator | Placebo + tramadol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naldemedine | Drug | Naldemedine is administered orally once daily in the morning in a dosage of 0.2 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:
Known hypersensitivity or allergy towards the used pharmaceutical compounds or pharmaceutical compounds similar to those used in the study.
History of substance abuse (alcohol, tetrahydrocannabinol, benzodiazepine, central stimulants and/or opioids, urine drug test will be performed prior to treatment start).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asbjørn Mohr Drewes | Contact | +45 97 66 35 62 | amd@rn.dk |
| Name | Affiliation | Role |
|---|---|---|
| Asbjørn Mohr Drewes | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Recruiting | Aalborg | 9000 | Denmark |
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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 |
|---|---|
| C000620491 | naldemedine |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Placebo | Drug | Placebo is administered orally once daily in the morning. |
|
| Tramadol | Drug | In both arms, tramadol is administered orally twice daily in a dosage of 100 mg (daily total of 200mg). |
|
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 | 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 |
| Defecation assessment | Analysis of rear-front pressure during a simulated defecation using the Fecobionics device | 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 |