MedDataX Logo

Codeine on Pharyngeal and Esophageal Motility

NCT ID: NCT03784105

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-07

Study Completion Date

2018-12-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Motility Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

codeine Esophageal motility Pharyngeal motility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Codeine

Group Type EXPERIMENTAL

Codeine Phosphate

Intervention Type DRUG

30 mL of codeine phosphate 10mg/5mL

Siripus simplex

Group Type PLACEBO_COMPARATOR

Siripus simplex

Intervention Type DRUG

Sugar syrup

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Codeine Phosphate

30 mL of codeine phosphate 10mg/5mL

Intervention Type DRUG

Siripus simplex

Sugar syrup

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jan Tack

Leuven, , Belgium

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33232555 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S60496

Identifier Type: -

Identifier Source: org_study_id