Codeine on Pharyngeal and Esophageal Motility

Phase 4

Completed

• Conditions: Esophageal Motility Disorders
• Interventions: Drug: Codeine Phosphate; Drug: Siripus simplex

• Registration Number: NCT03784105
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-07
• Status Verified: 2018-12
• Study First Submitted: 2018-12-11
• Primary Completion: 2018-12-14
• Study Completion: 2018-12-14
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-21
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Healthy volunteers aged between 18-60 years old
• Written informed consent

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Exclusion Criteria

• No chronic disease/medication
• No GI symptoms
• Not pregnant or breast-feeding
• No history of head/neck surgery
• Not allergic to codeine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Codeine	Codeine Phosphate	-
Siripus simplex	Siripus simplex	-

Primary Outcome Measures

Name	Time	Method
Difference in distal contractile integral	1 week	The difference in distal contractile integral between the codeine and placebo condition
Difference in integrated relaxation pressure	1 week	The difference in integrated relaxation pressure between the codeine and placebo condition
Difference in distal latency	1 week	The difference in distal latency between the codeine and placebo condition.
Difference in pressure flow	1 week	The difference in pressure flow between the codeine and placebo condition

Trial Locations

Locations (2)

Jan Tack; 🇧🇪 Leuven, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium