Gastro Esophageal RefluxPhase 4NCT03746691
Effect of Citalopram on Reflux Episodes in Healthy Volunteers
A Phase 4 study testing Citalopram HCl in people with Gastro Esophageal Reflux, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Citalopram is sometimes used in the treatment for gastro-esophageal reflux disease, however, there are no empirical data to support this. The investigators would like to know if citalopram has an effect on the lower esophageal sphincter pressure, transient lower esophageal sphincter relaxations and reflux episodes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- Citalopram HCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2017to 31 Jul 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 18 and 65 years
Who cannot join
- history of upper GI symptoms
- history of upper GI surgery
- psychological disorders
- any drug history
- use of medication altering GI motility
- nursing and pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Citalopram on Fasting and Postprandial Lower Esophageal Sphincter Function in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study
Citalopram is sometimes used in the treatment for gastro-esophageal reflux disease, however, there are no empirical data to support this. The investigators would like to know if citalopram has an effect on the lower esophageal sphincter pressure, transient lower esophageal sphincter relaxations and reflux episodes. The investigators will investigate this by performing high resolution impedance manometry in healthy volunteers before and after a solid meal. This will be compared to placebo, in a cross-over, randomized, double-blind condition.
- Conditions
- Gastro Esophageal Reflux
- Being tested
- Citalopram HCl, Placebos
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citalopram HClDrug
Citalopram HCl IV 20 mg in 100 ml saline will be infused IV over the course of 30 minutes. Volunteers will receive a standard meal, and recordings using high resolution impedance manometry, will be continued for 2 hours.
PlacebosDrug
Placebo (100 ml saline IV) will be infused IV over the course of 30 minutes. Volunteers will receive a standard meal, and recordings using high resolution impedance manometry, will be continued for 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Citalopram, 20 mg, IV | Experimental | After placement of a high resolution impedance manometry catheter (transnasally), citalopram will be administered IV over 30 minutes (20 mg in 100ml saline). Thereafter, the investigators will wait for 20 minutes, after which the volunteers will receive 10 wet swallows (5ml saline), to investigate esophageal peristalsis. Thereafter, a standard meal (1000kcal) will be given to the volunteers and recordings will continue for another 2 hours. Receives: Drug: Citalopram HCl |
| Placebo, IV | Placebo comparator | After placement of a high resolution impedance manometry catheter (transnasally), placebo (saline 100ml) will be administered IV over 30 minutes. Thereafter, the investigators will wait for 20 minutes, after which the volunteers will receive 10 wet swallows (5ml saline), to investigate esophageal peristalsis. Thereafter, a standard meal (1000kcal) will be given to the volunteers and recordings will continue for another 2 hours. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LES pressure
The investigators will measure lower esophageal sphincter pressure after a meal between placebo and citalopram, using a high resolution impedance manometry system. LES pressures will be measured in the first hour postprandial and will be compared (preprandial vs postprandial hour 1).
Measured: LES pressure will be measured for 4 times (a 5 sec time window) per hour. The average of the first hour will be taken as the LES pressure for the first hour postprandially.
Change in the number of reflux episodes
The investigators will measure the number of reflux episodes after a meal between placebo and citalopram, using a high resolution impedance manometry system.
Measured: The number of reflux episodes will be counted in a 3 hour time period, to have 1 number of reflux episodes.
Change in the number of TLESRs
The investigators will measure the number of transient lower esophageal sphincter relaxations after a meal between placebo and citalopram, using a high resolution impedance manometry system.
Measured: The total number of TLESRs will be counted in a 3 hour time period, to have 1 number of TLESRs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Feb 2017
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Jan Tack, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Jan Tack, Prof., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746691
- Sponsor's protocol ID
- S59148
- Status last verified
- Nov 2018
- First submitted
- 21 Mar 2017
- Last updated
- 20 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Citalopram on Fasting and Postprandial Lower Esophageal Sphincter Function in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study
- ClinicalTrials.gov ID
- NCT03746691
- Acronym / sponsor ID
- S59148
- Conditions
- Gastro Esophageal Reflux
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 20 Nov 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.
Citalopram is sometimes used in the treatment for gastro-esophageal reflux disease, however, there are no empirical data to support this. The investigators would like to know if citalopram has an effect on the lower esophageal sphincter pressure, transient lower esophageal sphincter relaxations and reflux episodes. The investigators will investigate this by performing high resolution impedance manometry in healthy volunteers before and after a solid meal. This will be compared to placebo, in a cross-over, randomized, double-blind condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citalopram, 20 mg, IV | Experimental | Drug: Citalopram HClAfter placement of a high resolution impedance manometry catheter (transnasally), citalopram will be administered IV over 30 minutes (20 mg in 100ml saline). Thereafter, the investigators will wait for 20 minutes, after which the volunteers will receive 10 wet swallows (5ml saline), to investigate esophageal peristalsis. Thereafter, a standard meal (1000kcal) will be given to the volunteers and recordings will continue for another 2 hours. |
| Placebo, IV | Placebo comparator | Drug: PlacebosAfter placement of a high resolution impedance manometry catheter (transnasally), placebo (saline 100ml) will be administered IV over 30 minutes. Thereafter, the investigators will wait for 20 minutes, after which the volunteers will receive 10 wet swallows (5ml saline), to investigate esophageal peristalsis. Thereafter, a standard meal (1000kcal) will be given to the volunteers and recordings will continue for another 2 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- between 18 and 65 years
Key exclusion criteria (6 listed)
- history of upper GI symptoms
- history of upper GI surgery
- psychological disorders
- any drug history
- use of medication altering GI motility
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 |
|---|---|---|
| Citalopram HClCitalopram HCl IV 20 mg in 100 ml saline will be infused IV over the course of 30 minutes. Volunteers will receive a standard meal, and recordings using high resolution impedance manometry, will be continued for 2 hours. | Drug | Citalopram, 20 mg, IV |
| PlacebosPlacebo (100 ml saline IV) will be infused IV over the course of 30 minutes. Volunteers will receive a standard meal, and recordings using high resolution impedance manometry, will be continued for 2 hours. | Drug | Placebo, IV |
Primary outcome
Change in LES pressure
Time frame: LES pressure will be measured for 4 times (a 5 sec time window) per hour. The average of the first hour will be taken as the LES pressure for the first hour postprandially.
The investigators will measure lower esophageal sphincter pressure after a meal between placebo and citalopram, using a high resolution impedance manometry system. LES pressures will be measured in the first hour postprandial and will be compared (preprandial vs postprandial hour 1).
Change in the number of reflux episodes
Time frame: The number of reflux episodes will be counted in a 3 hour time period, to have 1 number of reflux episodes.
The investigators will measure the number of reflux episodes after a meal between placebo and citalopram, using a high resolution impedance manometry system.
Change in the number of TLESRs
Time frame: The total number of TLESRs will be counted in a 3 hour time period, to have 1 number of TLESRs.
The investigators will measure the number of transient lower esophageal sphincter relaxations after a meal between placebo and citalopram, using a high resolution impedance manometry system.
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 20 Nov 2018.
- 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.
Jan Tack, Prof. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Citalopram HCl in people with Gastro Esophageal Reflux, run by Universitaire Ziekenhuizen KU Leuven at 1 site 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 1 inclusion and 6 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 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in LES pressure (time frame: LES pressure will be measured for 4 times (a 5 sec time window) per hour. The average of the first hour will be taken as the LES pressure for the first hour postprandially.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2018.