Codeine on Pharyngeal and Esophageal Motility

NCT ID: NCT03784105

Last Updated: 2018-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-07
• Study Completion Date: 2018-12-14

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).

Conditions

Esophageal Motility Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Codeine

Group Type: EXPERIMENTAL

Codeine Phosphate

Intervention Type: DRUG

30 mL of codeine phosphate 10mg/5mL

Siripus simplex

Group Type: PLACEBO_COMPARATOR

Siripus simplex

Intervention Type: DRUG

Sugar syrup

Interventions

Codeine Phosphate

30 mL of codeine phosphate 10mg/5mL

Intervention Type: DRUG

Siripus simplex

Sugar syrup

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jan Tack

Leuven, , Belgium

UZ Leuven

Leuven, , Belgium

Countries

Belgium

References

Geeraerts A, Geysen H, Ballet L, Hofmans C, Clevers E, Omari T, Manolakis AC, Mols R, Augustijns P, Vanuytsel T, Rommel N, Tack J, Pauwels A. Codeine induces increased resistance at the esophagogastric junction but has no effect on motility and bolus flow in the pharynx and upper esophageal sphincter in healthy volunteers: A randomized, double-blind, placebo-controlled, cross-over trial. Neurogastroenterol Motil. 2021 May;33(5):e14041. doi: 10.1111/nmo.14041. Epub 2020 Nov 24.

Reference Type: DERIVED

PMID: 33232555 (View on PubMed)

Other Identifiers

S60496

Identifier Type: -

Identifier Source: org_study_id