Effect of codeine on motility in the pharynx and esophagus in healthy subjects

Effect of codeine on pharyngeal and esophageal motility in healthy subjects: a double-blind, placebo-controlled, randomized, cross-over study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002349-30-BE

Enrollment

Registered

2017-06-13

Start date

2017-09-12

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

we will investigate the effect of codeine on motility in the pharynx and esophagus in healthy subjects

Interventions

Trade Name: Bronchodine 10mg/5ml Product Name: Bronchodine 10mg/5ml Pharmaceutical Form: Syrup Pharmaceutical form of the placebo: Syrup Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age > 18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - they are older than 60 years old and younger than 18 years; - they are taking medication altering the GI motility; - they have severely decreased kidney function; - they have severely decreased liver function; - they have severe heart disease, for example heart failure, angina, history of myocardial infarction, arrythmia; - they have severe lung disease (i.e. severe chronic obstructive pulmonary disease, pulmonary fibrosis, cystic fibrosis); - have prostate disorders; - they have severe psychiatric illness or neurological illness; - they have any gastrointestinal disease, upper GI symptoms or GI surgery; - they have history of head and neck surgery; - they are women that are pregnant or breastfeeding (details on menstrual cycle, date of last intercourse will be asked upon first visit by an experienced doctor); - they have a history of drug abuse; - they have known side-effects/allergic reactions when taking codeine/morphine.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of codeine on pharyngeal and esophageal motility in healthy subjects;Secondary Objective: NA;Primary end point(s): Forty completed visits, two per each of the 20 healthy volunteers during which they ingest codeine and placebo in a randomized double-blind cross-over fashion. Analysis of high resolution impedance manometry (HRiM) data will be performed to study motility patterns in the esophagus and pharynx. We will compare different HRiM parameters between placebo and codeine condition: • Distal contractile integral; • Integrated relaxation pressure; • Distal latency; • Pressure flow parameters. ;Timepoint(s) of evaluation of this end point: starting 45 min after administration of codeine or placebo for esophageal measurements, starting 75 min after administration for pharyngeal measurements	—

Measure

Time frame

Main Objective: To investigate the effect of codeine on pharyngeal and esophageal motility in healthy subjects;Secondary Objective: NA;Primary end point(s): Forty completed visits, two per each of the 20 healthy volunteers during which they ingest codeine and placebo in a randomized double-blind cross-over fashion. Analysis of high resolution impedance manometry (HRiM) data will be performed to study motility patterns in the esophagus and pharynx. We will compare different HRiM parameters between placebo and codeine condition: • Distal contractile integral; • Integrated relaxation pressure; • Distal latency; • Pressure flow parameters. ;Timepoint(s) of evaluation of this end point: starting 45 min after administration of codeine or placebo for esophageal measurements, starting 75 min after administration for pharyngeal measurements

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Belgium

Contacts

Public ContactTARGID

TARGID, KU Leuven

ans.pauwels@kuleuven.be3216330671

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026