THE EFFECT OF CODEINE ON GASTRIC MOTILITY AS MEASURED WITH AN INTRAGASTRIC BALLOON

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000867-18-BE

Enrollment

Registered

2016-03-03

Start date

2016-03-25

Completion date

Unknown

Last updated

2018-06-05

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

Conditions

gastroparesis

Interventions

Trade Name: Bronchodine 10mg/5ml syrup Product Name: Bronchodine 10 mg/5ml syrup Pharmaceutical Form: Syrup INN or Proposed INN: CODEINE PHOSPHATE HEMIHYDRATE CAS Number: 52-28-8 Other descriptive nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -They are between 18-60 years old. -Male and female. -Patients must provide witnessed written informed consent prior to any study procedures being performed. -They can go home without driving a vehicle -They will not operate machines on the same day of treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=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. -Have severely decreased kidney function. -Have severely decreased liver function. -Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack. -Have severe lung disease, asthma, chronic bronchorroe (bronchiectasis, cystic fibrosis). -Have severe psychiatric illness or neurological illness. -Have any gastrointestinal disease. -Have any dyspeptic symptoms. -Women that are pregnant or breastfeeding. -Take drugs -Have known side-effects/allergic reactions when taking codeine/morphine

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether measuring gastric pressure using a intragastric balloon can detect opioid-induced gastroparesis.;Secondary Objective: not applicable;Primary end point(s): To investigate whether measuring gastric pressure using a intragastric balloon can detect opioid-induced gastroparesis.;Timepoint(s) of evaluation of this end point: end of study	—

Secondary

Measure	Time frame
Secondary end point(s): not appl;Timepoint(s) of evaluation of this end point: not appl	—

Countries

Belgium

Contacts

Public ContactTARGID

KU Leuven

pieter.janssen@kuleuven.be32163474425

Outcome results

None listed

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