NCT03784105

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2018

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
Last Updated

December 24, 2018

Status Verified

December 1, 2018

Enrollment Period

1.3 years

First QC Date

December 11, 2018

Last Update Submit

December 21, 2018

Conditions

Esophageal Motility Disorders

Keywords

codeineEsophageal motilityPharyngeal motility

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Codeine

EXPERIMENTAL
Drug: Codeine Phosphate

Siripus simplex

PLACEBO COMPARATOR
Drug: Siripus simplex

Interventions

Codeine PhosphateDRUG

30 mL of codeine phosphate 10mg/5mL

Codeine
Siripus simplexDRUG

Sugar syrup

Siripus simplex

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers aged between 18-60 years old
  • Written informed consent

You may not qualify if:

  • No chronic disease/medication
  • No GI symptoms
  • Not pregnant or breast-feeding
  • No history of head/neck surgery
  • Not allergic to codeine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jan Tack

Leuven, 3000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 33232555DERIVED

MeSH Terms

Conditions

Esophageal Motility Disorders

Interventions

Codeine

Condition Hierarchy (Ancestors)

Deglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind, preparation and administration of codeine or placebo conducted by an independent researcher.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 21, 2018

Study Start

September 7, 2017

Primary Completion

December 14, 2018

Study Completion

December 14, 2018

Last Updated

December 24, 2018

Record last verified: 2018-12

Locations

BE(2)