Codeine on Pharyngeal and Esophageal Motility

Esophageal Motility Disorders Clinical Trial

Official title:

Effect of Codeine on Pharyngeal and Esophageal Motility in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03784105
• Other study ID #: S60496
• Status: Completed
• Phase: Phase 4
• Start date: September 7, 2017
• Est. completion date: December 14, 2018

Study information

• Verified date: December 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Opioids act on opioid receptors located in the brain as well as in the gastrointestinal (GI) tract to induce changes in motility. A variety of studies have linked chronic opioid use with changes in intestinal and to a lesser extent esophageal motility. Less is known about acute administration effects on distal esophageal motility and LES and even less with respect to proximal esophagus, UES and pharynx. Codeine, an opioid receptor agonist, by acting both centrally as well as in the periphery may induce changes in parts of the GI tract implicated in deglutition. Therefore, to evaluate the hypothesis the researchers will study motility patterns in the pharynx, UES, proximal and distal esophagus and LES in 22 healthy volunteers receiving placebo or codeine (60 mg) in a double-blind randomized cross-over controlled fashion. Motility patterns will be studied using state-of-the-art criteria and analytic tools (Chicago 3.0, AIMPlot analysis).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 14, 2018
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers aged between 18-60 years old

• Written informed consent

Exclusion Criteria:

• No chronic disease/medication

• No GI symptoms

• Not pregnant or breast-feeding

• No history of head/neck surgery

• Not allergic to codeine

Related Conditions & MeSH terms

• Esophageal Motility Disorders
• Esophageal Spasm, Diffuse

Intervention

Drug:
• Codeine Phosphate
30 mL of codeine phosphate 10mg/5mL
• Siripus simplex
Sugar syrup

Locations

Country	Name	City	State
Belgium	Jan Tack	Leuven
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in distal contractile integral	The difference in distal contractile integral between the codeine and placebo condition	1 week
Primary	Difference in integrated relaxation pressure	The difference in integrated relaxation pressure between the codeine and placebo condition	1 week
Primary	Difference in distal latency	The difference in distal latency between the codeine and placebo condition.	1 week
Primary	Difference in pressure flow	The difference in pressure flow between the codeine and placebo condition	1 week