Codeine on Pharyngeal and Esophageal Motility
Primary Purpose
Esophageal Motility Disorders
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Codeine Phosphate
Siripus simplex
Sponsored by
About this trial
This is an interventional other trial for Esophageal Motility Disorders focused on measuring codeine, Esophageal motility, Pharyngeal motility
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers aged between 18-60 years old
- Written informed consent
Exclusion Criteria:
- No chronic disease/medication
- No GI symptoms
- Not pregnant or breast-feeding
- No history of head/neck surgery
- Not allergic to codeine
Sites / Locations
- Jan Tack
- UZ Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Codeine
Siripus simplex
Arm Description
Outcomes
Primary Outcome Measures
Difference in distal contractile integral
The difference in distal contractile integral between the codeine and placebo condition
Difference in integrated relaxation pressure
The difference in integrated relaxation pressure between the codeine and placebo condition
Difference in distal latency
The difference in distal latency between the codeine and placebo condition.
Difference in pressure flow
The difference in pressure flow between the codeine and placebo condition
Secondary Outcome Measures
Full Information
NCT ID
NCT03784105
First Posted
December 11, 2018
Last Updated
December 21, 2018
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT03784105
Brief Title
Codeine on Pharyngeal and Esophageal Motility
Official Title
Effect of Codeine on Pharyngeal and Esophageal Motility in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
December 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Motility Disorders
Keywords
codeine, Esophageal motility, Pharyngeal motility
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blind, preparation and administration of codeine or placebo conducted by an independent researcher.
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Codeine
Arm Type
Experimental
Arm Title
Siripus simplex
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Codeine Phosphate
Intervention Description
30 mL of codeine phosphate 10mg/5mL
Intervention Type
Drug
Intervention Name(s)
Siripus simplex
Intervention Description
Sugar syrup
Primary Outcome Measure Information:
Title
Difference in distal contractile integral
Description
The difference in distal contractile integral between the codeine and placebo condition
Time Frame
1 week
Title
Difference in integrated relaxation pressure
Description
The difference in integrated relaxation pressure between the codeine and placebo condition
Time Frame
1 week
Title
Difference in distal latency
Description
The difference in distal latency between the codeine and placebo condition.
Time Frame
1 week
Title
Difference in pressure flow
Description
The difference in pressure flow between the codeine and placebo condition
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers aged between 18-60 years old
Written informed consent
Exclusion Criteria:
No chronic disease/medication
No GI symptoms
Not pregnant or breast-feeding
No history of head/neck surgery
Not allergic to codeine
Facility Information:
Facility Name
Jan Tack
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33232555
Citation
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.
Results Reference
derived
Learn more about this trial
Codeine on Pharyngeal and Esophageal Motility
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