THE RELATIONSHIP BETWEEN GASTRIC MOTILITY AND EMPTYING AS MEASURED WITH AN INTRAGASTRIC BALLOON AND BREATH TESTING

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002889-32-BE

Enrollment

Registered

2016-07-11

Start date

2016-08-03

Completion date

Unknown

Last updated

2018-01-08

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/5 ml syrup Product Name: Bronchodine 10mg/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 the relation between gastric motility and gastric emptying in healthy control volunteers (codeine vs. placebo).;Secondary Objective: not applicable;Primary end point(s): to investigate the relation between gastric motility and gastric emptying in healthy control volunteers (codeine vs. placebo).;Timepoint(s) of evaluation of this end point: end of study	—

Secondary

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

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