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Opioids act on opioid receptors located in the brain as well as in the gastrointestinal (GI) tract to induce changes in motility. A variety of studies have linked chronic opioid use with changes in intestinal and to a lesser extent esophageal motility. Less is known about acute administration effects on distal esophageal motility and LES and even less with respect to proximal esophagus, UES and pharynx. Codeine, an opioid receptor agonist, by acting both centrally as well as in the periphery may induce changes in parts of the GI tract implicated in deglutition. Therefore, to evaluate the hypothesis the researchers will study motility patterns in the pharynx, UES, proximal and distal esophagus and LES in 22 healthy volunteers receiving placebo or codeine (60 mg) in a double-blind randomized cross-over controlled fashion. Motility patterns will be studied using state-of-the-art criteria and analytic tools (Chicago 3.0, AIMPlot analysis).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Codeine | Experimental |
| |
| Siripus simplex | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Codeine Phosphate | Drug | 30 mL of codeine phosphate 10mg/5mL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in distal contractile integral | The difference in distal contractile integral between the codeine and placebo condition | 1 week |
| Difference in integrated relaxation pressure | The difference in integrated relaxation pressure between the codeine and placebo condition | 1 week |
| Difference in distal latency | The difference in distal latency between the codeine and placebo condition. | 1 week |
| Difference in pressure flow | The difference in pressure flow between the codeine and placebo condition | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jan Tack | Leuven | 3000 | Belgium | |||
| UZ Leuven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33232555 | Derived | Geeraerts A, Geysen H, Ballet L, Hofmans C, Clevers E, Omari T, Manolakis AC, Mols R, Augustijns P, Vanuytsel T, Rommel N, Tack J, Pauwels A. Codeine induces increased resistance at the esophagogastric junction but has no effect on motility and bolus flow in the pharynx and upper esophageal sphincter in healthy volunteers: A randomized, double-blind, placebo-controlled, cross-over trial. Neurogastroenterol Motil. 2021 May;33(5):e14041. doi: 10.1111/nmo.14041. Epub 2020 Nov 24. |
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| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003061 | Codeine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers
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Double-blind, preparation and administration of codeine or placebo conducted by an independent researcher.
| Siripus simplex |
| Drug |
Sugar syrup |
|
| Leuven |
| 3000 |
| Belgium |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |