Esophagogastroduodensocopy (EGD) ProcedurePhase 4NCT07264738
Oral Ondansetron to Improve Patient Experience of Unsedated Esophagogastroduodenoscopy Pilot Study
A Phase 4 study testing ondansetron and dyclonine hydrochloride and dyclonine hydrochloride only in people with Esophagogastroduodensocopy (EGD) Procedure, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this interventional pilot study is to explore the feasibility of administering ondansetron prior to esophagogastroduodenoscopy (EGD), and preliminarily test if it can alleviate the gagging reflex, nausea and vomiting in Chinese patients undergoing unsedated diagnostic EGD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Esophagogastroduodensocopy (EGD) Procedure
- What is being tested?
- ondansetron and dyclonine hydrochloride and dyclonine hydrochloride only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 10 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for follow-up EGD at PUMCH
- Signing a written informed consent.
Who cannot join
- Contraindications for esophagogastroduodenoscopy.
- History of upper gastrointestinal tract surgery.
- With conditions indicated for emergency EGD, such as upper gastrointestinal bleeding
- Severe diseases of the heart, kidney, respiratory system, central nervous system, and hematopoietic system.
- Pregnancy.
- Neuropsychiatric disorders, severe depression and severe anxiety.
- Allergy to ondansetron or dyclonine hydrochloride.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Oral Ondansetron to Improve Patient Experience of Unsedated Esophagogastroduodenoscopy: A Pilot Study
The goal of this interventional pilot study is to explore the feasibility of administering ondansetron prior to esophagogastroduodenoscopy (EGD), and preliminarily test if it can alleviate the gagging reflex, nausea and vomiting in Chinese patients undergoing unsedated diagnostic EGD. The main questions it aims to answer are:
Is adding oral ondansetron to pre-medication regimen of unsedated EGD safe, easy to conduct, and well-accepted by patients? May taking ondansetron prior to EGD reduce the discomfort of patients during the endoscopic process? May taking ondansetron prior to EGD reduce the intensity of patient gagging and nausea, and the incidence of vomiting ? Researchers will compare premedication of oral ondasetron and topical pharyngeal anesthesia (dyclonine hydrochloride mucilage) with topical pharyngeal anesthesia only to answer the questions above.
Read more
Participants will be treated with one of the following regimens according to the randomization result:
- Oral ondansetron of 8 mg 2 hours prior to endoscopic process and dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process;
- dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process.
After the endoscopic process is finished, patients will be asked to fill in a questionnaire that contains the following items, all measured by NRS 0-10:
- Overall discomfort;
- Intensity of gagging;
- Willingness to undergo unsedated EGD again if indicated.
- Being tested
- ondansetron and dyclonine hydrochloride, dyclonine hydrochloride only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ondansetron and dyclonine hydrochlorideDrug
Patients will take 8 mg oral ondansetron 2 hours prior to EGD process in addition to dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to EGD process.
dyclonine hydrochloride onlyDrug
Patients will be instructed to gurgle 10 mL of dyclonine chloride mucilage (0.01 g/mL) and gurgle for 1 minute 15 minutes prior to endoscopic process.
| Study group | Role | What they receive |
|---|---|---|
| oral ondansetron and dyclonine hydrochloride mucilage | Experimental | Not described Receives: Drug: ondansetron and dyclonine hydrochloride |
| dyclonine hydrochloride mucilage only | Other | Not described Receives: Drug: dyclonine hydrochloride only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall discomfort
All 20 patients were follow-up patients who had unsedated EGD before. They assessed their degree of overall discomfort during the curent examination and the previous examination, both in numeric rating scale (NRS, on a scale from 0 to 10, 0 means no discomfort, 10 means extremely uncomfortable). Change in overall discomfort is the value of the difference between the previous and current NRS (previous-current).
Measured: from the previous endoscopy to 30 minutes after the current endoscopy is finished
Secondary outcomes (4)
Change in patient gagging intensity
Patients assessed their gagging intensity during the curent examination and the previous examination, both in NRS 0-10, 0 means no gagging, 10 means extremely intense gagging. Change in overall discomfort is the value of the difference between the previous and current NRS (previous-current).
Measured: from the previous endoscopic examination to 30 minutes after the current examination is finished.
Patient willingness to undergo unsedated EGD again
the willingness of patients to undergo unsedated EGD in the same method again, assessed by NRS 0-10 (0, not willing at all; 10 completely willing).
Measured: from start of endoscopy to 30 minutes after the examination is finished
Intensity of patient gagging evaluated by endoscopist
measured by NRS 0-10, (0 none, 10 extremely strong) in a questionnaire given to endoscopists after the endoscopic process is finished
Measured: from the start of the endoscopic process to the end of the endoscopic process
Endoscopist satisfaction for patient cooperation
satisfaction of endoscopist for patient cooperation in this process, assessed by NRS 0-10 (0, not satisfied at all; 10 very satisfied).
Measured: from the start to the end of the endoscopic process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Jul 2025
- Primary completion28 Sep 2025
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastroduodensocopy (EGD) ProcedureStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DONG WU, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264738
- Sponsor's protocol ID
- ON-COMFORT25
- Status last verified
- Apr 2026
- First submitted
- 23 Nov 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Ondansetron to Improve Patient Experience of Unsedated Esophagogastroduodenoscopy: A Pilot Study
- ClinicalTrials.gov ID
- NCT07264738
- Acronym / sponsor ID
- ON-COMFORT25
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 28 Sep 2025 (actual)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 4 Dec 2025 (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.
The goal of this interventional pilot study is to explore the feasibility of administering ondansetron prior to esophagogastroduodenoscopy (EGD), and preliminarily test if it can alleviate the gagging reflex, nausea and vomiting in Chinese patients undergoing unsedated diagnostic EGD. The main questions it aims to answer are:
Is adding oral ondansetron to pre-medication regimen of unsedated EGD safe, easy to conduct, and well-accepted by patients? May taking ondansetron prior to EGD reduce the discomfort of patients during the endoscopic process? May taking ondansetron prior to EGD reduce the intensity of patient gagging and nausea, and the incidence of vomiting ? Researchers will compare premedication of oral ondasetron and topical pharyngeal anesthesia (dyclonine hydrochloride mucilage) with topical pharyngeal anesthesia only to answer the questions above.
Participants will be treated with one of the following regimens according to the randomization result:
- Oral ondansetron of 8 mg 2 hours prior to endoscopic process and dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process;
- dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process.
After the endoscopic process is finished, patients will be asked to fill in a questionnaire that contains the following items, all measured by NRS 0-10:
- Overall discomfort;
- Intensity of gagging;
- Willingness to undergo unsedated EGD again if indicated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral ondansetron and dyclonine hydrochloride mucilage | Experimental | Drug: ondansetron and dyclonine hydrochloride |
| dyclonine hydrochloride mucilage only | Other | Drug: dyclonine hydrochloride only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients scheduled for follow-up EGD at PUMCH
- Signing a written informed consent.
Key exclusion criteria (7 listed)
- Contraindications for esophagogastroduodenoscopy.
- History of upper gastrointestinal tract surgery.
- With conditions indicated for emergency EGD, such as upper gastrointestinal bleeding
- Severe diseases of the heart, kidney, respiratory system, central nervous system, and hematopoietic system.
- Pregnancy.
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 |
|---|---|---|
| ondansetron and dyclonine hydrochloridePatients will take 8 mg oral ondansetron 2 hours prior to EGD process in addition to dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to EGD process. | Drug | oral ondansetron and dyclonine hydrochloride mucilage |
| dyclonine hydrochloride onlyPatients will be instructed to gurgle 10 mL of dyclonine chloride mucilage (0.01 g/mL) and gurgle for 1 minute 15 minutes prior to endoscopic process. | Drug | dyclonine hydrochloride mucilage only |
Primary outcome
Change in overall discomfort
Time frame: from the previous endoscopy to 30 minutes after the current endoscopy is finished
All 20 patients were follow-up patients who had unsedated EGD before. They assessed their degree of overall discomfort during the curent examination and the previous examination, both in numeric rating scale (NRS, on a scale from 0 to 10, 0 means no discomfort, 10 means extremely uncomfortable). Change in overall discomfort is the value of the difference between the previous and current NRS (previous-current).
4 secondary outcomes
Change in patient gagging intensity
Time frame: from the previous endoscopic examination to 30 minutes after the current examination is finished.
Patient willingness to undergo unsedated EGD again
Time frame: from start of endoscopy to 30 minutes after the examination is finished
Intensity of patient gagging evaluated by endoscopist
Time frame: from the start of the endoscopic process to the end of the endoscopic process
Endoscopist satisfaction for patient cooperation
Time frame: from the start to the end of the endoscopic process
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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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.
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 ondansetron and dyclonine hydrochloride and dyclonine hydrochloride only in people with Esophagogastroduodensocopy (EGD) Procedure, run by Peking Union Medical College Hospital at 1 site in China.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. 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 China. 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. 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?
This study is still under way. Results are not available in the source record yet.
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 overall discomfort (time frame: from the previous endoscopy to 30 minutes after the current endoscopy is finished). 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 1 May 2026.