Esophageal Food Bolus ObstructionPhase 4ONEFITNCT03305848
Esophageal Food Impaction
A Phase 4 study testing Nitrostat 0.4Mg Sublingual Tablet in people with Esophageal Food Bolus Obstruction, run by HealthPartners Institute at 1 site in United States.
Trial summary
This study is designed to obtain data on the safety and efficacy of oral nitroglycerin solution for the treatment of esophageal food impaction in patients presenting to the Emergency Department with presumed esophageal food impaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Food Bolus Obstruction
- What is being tested?
- Nitrostat 0.4Mg Sublingual Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2017to 4 Apr 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18 years
- Presentation consistent with esophageal food impaction
- Ability to swallow a small volume of liquid.
Who cannot join
- Intractable vomiting
- Hemodynamic instability or SBP <100 mmHg
- Concern for or evidence of significant airway compromise
- Concern for or evidence of esophageal perforation,
- Concern for or evidence of coronary ischemia
- Presentation > 12 hours since onset.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Oral Nitroglycerin on Esophageal Food Impaction
This study is designed to obtain data on the safety and efficacy of oral nitroglycerin solution for the treatment of esophageal food impaction in patients presenting to the Emergency Department with presumed esophageal food impaction. The main hypothesis is to determine the success rate of oral nitroglycerin solution in relieving the food impaction by assessing the resolution of symptoms and the ability of the patient to swallow.
Read the detailed description
A piece of food stuck in the esophagus (the tube connecting the mouth to the stomach) is a relatively common occurrence, estimated at a rate of 13 episodes per 100,000 people per year, mostly men, and usually attributed to swallowed meat. The current standard of care for patients presenting to an Emergency Department with this problem includes a trial of medication, usually glucagon but sometimes a carbonated beverage, an injection of nitroglycerin, or benzodiazepines. The medical interventions mentioned above have not been shown to be significantly effective and have unwanted side effects; glucagon is known to cause nausea and vomiting and benzodiazepines can cause sedation and depressed breathing. If the medication fails to relieve the problem, the patient may require a procedure called endoscopy, where a video scope and retrieval tool are inserted into the esophagus to remove the piece of food. There is significant risk associated with endoscopy, including the risks of anesthesia as well as with the physical procedure itself. Endoscopy also results in a prolonged hospital stay due to the time required for the procedure, as well as from anesthesia recovery. The ideal treatment would be a safe, inexpensive, quickly effective medication without significant side effects that could be administered without sedation or extensive monitoring. Oral nitroglycerin solution might just be that intervention.
- Conditions
- Esophageal Food Bolus Obstruction
- Being tested
- Nitrostat 0.4Mg Sublingual Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrostat 0.4Mg Sublingual TabletDrug
Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes, and only if systolic blood pressure > 100 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Oral nitroglycerin solution | Other | Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes Receives: Drug: Nitrostat 0.4Mg Sublingual Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Condition at Discharge
the proportion of study patients who achieve resolution of food impaction
Measured: Length of Emergency Department stay (Time Frame: up to 12 hours)]
Medications/Procedures Performed During Visit
Total number of other medications or procedures used to relieve the esophageal food impaction
Measured: Length of Emergency Department stay (Time Frame: up to 12 hours)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start25 Aug 2017
- Primary completion4 Apr 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal Food Bolus ObstructionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam Stellpflug, MD, Principal investigator, Regions Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305848
- Sponsor's protocol ID
- A17-134
- Acronym
- ONEFIT
- Status last verified
- Sep 2018
- First submitted
- 14 Sep 2017
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Nitroglycerin on Esophageal Food Impaction
- ClinicalTrials.gov ID
- NCT03305848
- Acronym / sponsor ID
- ONEFIT / A17-134
- Conditions
- Esophageal Food Bolus Obstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 10 Oct 2017 (actual)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to obtain data on the safety and efficacy of oral nitroglycerin solution for the treatment of esophageal food impaction in patients presenting to the Emergency Department with presumed esophageal food impaction. The main hypothesis is to determine the success rate of oral nitroglycerin solution in relieving the food impaction by assessing the resolution of symptoms and the ability of the patient to swallow.
Detailed description
A piece of food stuck in the esophagus (the tube connecting the mouth to the stomach) is a relatively common occurrence, estimated at a rate of 13 episodes per 100,000 people per year, mostly men, and usually attributed to swallowed meat. The current standard of care for patients presenting to an Emergency Department with this problem includes a trial of medication, usually glucagon but sometimes a carbonated beverage, an injection of nitroglycerin, or benzodiazepines. The medical interventions mentioned above have not been shown to be significantly effective and have unwanted side effects; glucagon is known to cause nausea and vomiting and benzodiazepines can cause sedation and depressed breathing. If the medication fails to relieve the problem, the patient may require a procedure called endoscopy, where a video scope and retrieval tool are inserted into the esophagus to remove the piece of food. There is significant risk associated with endoscopy, including the risks of anesthesia as well as with the physical procedure itself. Endoscopy also results in a prolonged hospital stay due to the time required for the procedure, as well as from anesthesia recovery. The ideal treatment would be a safe, inexpensive, quickly effective medication without significant side effects that could be administered without sedation or extensive monitoring. Oral nitroglycerin solution might just be that intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral nitroglycerin solution | Other | Drug: Nitrostat 0.4Mg Sublingual TabletUp to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over the age of 18 years
- Presentation consistent with esophageal food impaction
- Ability to swallow a small volume of liquid.
Key exclusion criteria (6 listed)
- Intractable vomiting
- Hemodynamic instability or SBP <100 mmHg
- Concern for or evidence of significant airway compromise
- Concern for or evidence of esophageal perforation,
- Concern for or evidence of coronary ischemia
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 |
|---|---|---|
| Nitrostat 0.4Mg Sublingual TabletUp to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes, and only if systolic blood pressure > 100 mmHg. | Drug | Oral nitroglycerin solution |
Primary outcome
Patients Condition at Discharge
Time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)]
the proportion of study patients who achieve resolution of food impaction
Medications/Procedures Performed During Visit
Time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)]
Total number of other medications or procedures used to relieve the esophageal food impaction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Esophageal Food Bolus Obstruction
RecruitingObservational study
Point of Care Ultrasound for the Detection of Esophageal Food Bolus
Esophageal Foreign Body, Esophageal Obstruction
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.
Sam Stellpflug, MD principal investigator
Regions Hospital
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 Nitrostat 0.4Mg Sublingual Tablet in people with Esophageal Food Bolus Obstruction, run by HealthPartners Institute at 1 site in United States.
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 3 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 8 Feb 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patients Condition at Discharge (time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)]). The study lists 2 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 8 Feb 2023.