Trial Outcomes & Findings for Esophageal Food Impaction (NCT NCT03305848)
NCT ID: NCT03305848
Last Updated: 2023-02-08
Results Overview
the proportion of study patients who achieve resolution of food impaction
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Length of Emergency Department stay (Time Frame: up to 12 hours)]
Results posted on
2023-02-08
Participant Flow
20 patients were enrolled who met inclusion for the study.
Participant milestones
| Measure |
Oral Nitroglycerin Solution
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
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.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Oral Nitroglycerin Solution
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
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.
|
|---|---|
|
Overall Study
Symptom resolution after consent, but before study drug administration
|
1
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Oral Nitroglycerin Solution
n=20 Participants
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
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=20 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 19.08230098 • n=20 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Length of Emergency Department stay (Time Frame: up to 12 hours)]Population: 17 of 20 enrolled subjects received the intervention
the proportion of study patients who achieve resolution of food impaction
Outcome measures
| Measure |
Oral Nitroglycerin Solution
n=17 Participants
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
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
Resolution with study treatment
|
2 Participants
|
|
Patients Condition at Discharge
Failure of resolution with study treatment
|
15 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Oral Nitroglycerin Solution
n=17 Participants
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
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.
|
|---|---|
|
Medications/Procedures Performed During Visit
Received additional medication
|
7 Participants
|
|
Medications/Procedures Performed During Visit
Underwent endoscopy
|
15 Participants
|
Adverse Events
Oral Nitroglycerin Solution
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral Nitroglycerin Solution
n=17 participants at risk
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
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.
|
|---|---|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Number of events 1 • 7 days
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Number of events 2 • 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place