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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03784105
Other study ID # S60496
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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