A Phase 4 interventional study of Nitrostat 0.4Mg Sublingual Tablet in Esophageal Food Bolus Obstruction, sponsored by HealthPartners Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by HealthPartners Institute · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
Drug: Nitrostat 0.4Mg Sublingual Tablet
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.
Patients Condition at Discharge
the proportion of study patients who achieve resolution of food impaction
Time frame: 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
Time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)]
| Milestone | Oral Nitroglycerin Solution |
|---|---|
| Started | 20 |
| Completed | 17 |
| Not completed | 3 |
| Withdrew: Symptom resolution after consent, but before study drug administration | 1 |
| Withdrew: Physician decision | 2 |
the proportion of study patients who achieve resolution of food impaction
| Participants | Oral Nitroglycerin Solution |
|---|---|
| Resolution with study treatment | 2 |
| Failure of resolution with study treatment | 15 |
Total number of other medications or procedures used to relieve the esophageal food impaction
| Participants | Oral Nitroglycerin Solution |
|---|---|
| Received additional medication | 7 |
| Underwent endoscopy | 15 |
Collected over 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Nitroglycerin Solution | 0/17 (0%) | 0/17 (0%) | 3/17 (17.6%) |
| Event | Oral Nitroglycerin Solution |
|---|---|
| HeadacheNervous system disorders | 2/17 |
| HypotensionVascular disorders | 1/17 |
17 of the 20 subjects received the study intervention.
| Age, Categorical(Participants) | Oral Nitroglycerin Solution |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 18 |
| >=65 years | 2 |
| Age, Continuous(years) | Oral Nitroglycerin Solution |
|---|---|
| Mean | 47 ± 19.08230098 |
| Sex: Female, Male(Participants) | Oral Nitroglycerin Solution |
|---|---|
| Female | 4 |
| Male | 16 |
| Race and Ethnicity Not Collected(Participants) | Oral Nitroglycerin Solution |
|---|
| Region of Enrollment(participants) | Oral Nitroglycerin Solution |
|---|---|
| United States | 20 |
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HealthPartners Institute