Esophageal Motility DisordersPhase 4NCT03784105
Codeine on Pharyngeal and Esophageal Motility
A Phase 4 study testing Codeine Phosphate and Siripus simplex in people with Esophageal Motility Disorders, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Motility Disorders
- What is being tested?
- Codeine Phosphate and Siripus simplex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesBelgium
- Study dates
- 7 Sep 2017to 14 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged between 18-60 years old
- Written informed consent
Who cannot join
- No chronic disease/medication
- No GI symptoms
- Not pregnant or breast-feeding
- No history of head/neck surgery
- Not allergic to codeine
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effect of Codeine on Pharyngeal and Esophageal Motility in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study
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
- Being tested
- Codeine Phosphate, Siripus simplex
- Keywords
- codeine, Esophageal motility, Pharyngeal motility
- Medical subject headings
- Esophageal Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Codeine PhosphateDrug
30 mL of codeine phosphate 10mg/5mL
Siripus simplexDrug
Sugar syrup
| Study group | Role | What they receive |
|---|---|---|
| Codeine | Experimental | Not described Receives: Drug: Codeine Phosphate |
| Siripus simplex | Placebo comparator | Not described Receives: Drug: Siripus simplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in distal contractile integral
The difference in distal contractile integral between the codeine and placebo condition
Measured: 1 week
Difference in integrated relaxation pressure
The difference in integrated relaxation pressure between the codeine and placebo condition
Measured: 1 week
Difference in distal latency
The difference in distal latency between the codeine and placebo condition.
Measured: 1 week
Difference in pressure flow
The difference in pressure flow between the codeine and placebo condition
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start7 Sep 2017
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Motility DisordersStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784105
- Sponsor's protocol ID
- S60496
- Status last verified
- Dec 2018
- First submitted
- 11 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33232555
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Codeine on Pharyngeal and Esophageal Motility in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study
- ClinicalTrials.gov ID
- NCT03784105
- Acronym / sponsor ID
- S60496
- Conditions
- Esophageal Motility Disorders
- Keywords
- codeine, Esophageal motility, Pharyngeal motility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 21 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| Codeine | Experimental | Drug: Codeine Phosphate |
| Siripus simplex | Placebo comparator | Drug: Siripus simplex |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers aged between 18-60 years old
- Written informed consent
Key exclusion criteria (5 listed)
- No chronic disease/medication
- No GI symptoms
- Not pregnant or breast-feeding
- No history of head/neck surgery
- Not allergic to codeine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Codeine Phosphate30 mL of codeine phosphate 10mg/5mL | Drug | Codeine |
| Siripus simplexSugar syrup | Drug | Siripus simplex |
Primary outcome
Difference in distal contractile integral
Time frame: 1 week
The difference in distal contractile integral between the codeine and placebo condition
Difference in integrated relaxation pressure
Time frame: 1 week
The difference in integrated relaxation pressure between the codeine and placebo condition
Difference in distal latency
Time frame: 1 week
The difference in distal latency between the codeine and placebo condition.
Difference in pressure flow
Time frame: 1 week
The difference in pressure flow between the codeine and placebo condition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Derived from this study: PubMed 33232555Geeraerts 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Codeine Phosphate and Siripus simplex in people with Esophageal Motility Disorders, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in distal contractile integral (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03784105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.