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Completed

NCT Number: NCT03784105

Codeine on Pharyngeal and Esophageal Motility

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).

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Key information

Conditions

Esophageal Motility Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jan Tack, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Codeine Phosphate

Drug

30 mL of codeine phosphate 10mg/5mL

Siripus simplex

Drug

Sugar syrup

Primary outcomes

  1. Difference in distal contractile integral

    Time frame: 1 week

    The difference in distal contractile integral between the codeine and placebo condition

  2. Difference in integrated relaxation pressure

    Time frame: 1 week

    The difference in integrated relaxation pressure between the codeine and placebo condition

  3. Difference in distal latency

    Time frame: 1 week

    The difference in distal latency between the codeine and placebo condition.

  4. Difference in pressure flow

    Time frame: 1 week

    The difference in pressure flow between the codeine and placebo condition

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2018
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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