Codeine on Pharyngeal and Esophageal Motility

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT03784105

Collaborator

(none)

Enrollment

Locations

Arms

15.2

Actual Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Esophageal Motility Disorders	Drug: Codeine Phosphate Drug: Siripus simplex	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteersDouble-blind, placebo-controlled, randomized, cross-over study in healthy volunteers

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Double-blind, preparation and administration of codeine or placebo conducted by an independent researcher.

Primary Purpose:

Other

Official Title:

Effect of Codeine on Pharyngeal and Esophageal Motility in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study

Actual Study Start Date :

Sep 7, 2017

Actual Primary Completion Date :

Dec 14, 2018

Actual Study Completion Date :

Dec 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Codeine	Drug: Codeine Phosphate 30 mL of codeine phosphate 10mg/5mL
Placebo Comparator: Siripus simplex	Drug: Siripus simplex Sugar syrup

Arm

Intervention/Treatment

Experimental: Codeine

Drug: Codeine Phosphate

30 mL of codeine phosphate 10mg/5mL

Placebo Comparator: Siripus simplex

Drug: Siripus simplex

Sugar syrup

Outcome Measures

Primary Outcome Measures

Difference in distal contractile integral [1 week]
The difference in distal contractile integral between the codeine and placebo condition
Difference in integrated relaxation pressure [1 week]
The difference in integrated relaxation pressure between the codeine and placebo condition
Difference in distal latency [1 week]
The difference in distal latency between the codeine and placebo condition.
Difference in pressure flow [1 week]
The difference in pressure flow between the codeine and placebo condition

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jan Tack	Leuven		Belgium	3000
2	UZ Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT03784105

Other Study ID Numbers:

S60496

First Posted:

Dec 21, 2018

Last Update Posted:

Dec 24, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Universitaire Ziekenhuizen Leuven

codeine

Esophageal motility

Pharyngeal motility

Additional relevant MeSH terms:

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Codeine

Study Results

No Results Posted as of Dec 24, 2018