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

Phase 1

• Conditions: we will investigate the effect of codeine on motility in the pharynx and esophagus in healthy subjects; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2017-002349-30-BE
• Lead Sponsor: TARGID, KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-13
• Study Completion: 2019-07-30
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

age > 18 and < 60 years
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 20
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 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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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. <br>We will compare different HRiM parameters between placebo and codeine condition: <br>• Distal contractile integral;<br>• Integrated relaxation pressure;<br>• Distal latency;<br>• Pressure flow parameters. <br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA