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Codeine on Pharyngeal and Esophageal Motility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03784105
Recruitment Status : Completed
First Posted : December 21, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen 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).

Condition or disease Intervention/treatment Phase
Esophageal Motility Disorders Drug: Codeine Phosphate Drug: Siripus simplex Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double-blind, preparation and administration of codeine or placebo conducted by an independent researcher.
Primary Purpose: Other
Official Title: Effect of Codeine on Pharyngeal and Esophageal Motility in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study
Actual Study Start Date : September 7, 2017
Actual Primary Completion Date : December 14, 2018
Actual Study Completion Date : December 14, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Codeine Drug: Codeine Phosphate
30 mL of codeine phosphate 10mg/5mL

Placebo Comparator: Siripus simplex Drug: Siripus simplex
Sugar syrup




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784105


Locations
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Belgium
Jan Tack
Leuven, Belgium, 3000
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03784105     History of Changes
Other Study ID Numbers: S60496
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
codeine
Esophageal motility
Pharyngeal motility
Additional relevant MeSH terms:
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Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Codeine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents