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

Phase 1

• Conditions: gastroparesis; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2016-000867-18-BE
• Lead Sponsor: KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-03
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): not appl;Timepoint(s) of evaluation of this end point: not appl