Nitroglycerin for Esophageal Food Impaction

Start 12 Jun 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites · Protocol MK2021

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ongoing, recruiting

Participants planned 88

Countries 1

Sites 2

Esophageal Food Impaction

To evaluate the efficacy of treatment with nitroglycerin for esophageal food impaction (EFI)

Key facts

Sponsor: Region Hovedstaden
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Otorhinolaryngologic Diseases [C09], Diseases [C] - Digestive System Diseases [C06]
Trial duration: 12 Jun 2025 → ongoing
Decision date (initial): 2023-08-28
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To evaluate the efficacy of treatment with nitroglycerin for esophageal food impaction (EFI)

Conditions and MedDRA coding

Esophageal Food Impaction

Version	Level	Code	Term	System organ class
20.1	LLT	10065575	Esophageal food impaction	10017947

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Age above 18 years 2. Presentation consistent with EFI for minimum 1 hour 3. Informed consent

Exclusion criteria 1

1. Sharp foreign body in the oesophagus (e.g. chicken bone) 2. Known structural abnormality in the oesophagus 3. Previous esophageal perforation 4. Recent use of phosphodiesterase inhibitors 5. Unresolved severe cardiac disease 6. Circulatory unstable patient 7. Systolic blood pressure < 100 mg 8. Known severe liver disease 9. Pregnancy or Breastfeeding 10. Any other disease/condition judged by the investigator to be grounds for exclusion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

• The number of patients with resolution of EFI without the need of endoscopic removal when treated with nitroglycerin (NGT) compared to the number of patients with resolution of EFI when treated with placebo.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Nitroglycerin "DAK", sublinguale resoribletter

PRD9261251 · Product

Active substance: Glyceryl Trinitrate
Pharmaceutical form: SUBLINGUAL TABLET
Route of administration: ORAL USE
Max daily dose: 1 mg milligram(s)
Max total dose: 1 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: C01DA02 — GLYCERYL TRINITRATE
Marketing authorisation: 07404
MA holder: ORIFARM HEALTHCARE A/S
MA country: Denmark
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Placebo 2

Placebo

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

Placebo 6 mm convex. White, round and normal convex tablets. Size 6 mm. The placebo is developed at the Capital Region Pharmacy in Denmark. The formulation is identical with a marketed SAD tablet but without active ingredient. Therefore no specific documentation for the pharmaceutical development is made.

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstaden

Sponsor organisation: Region Hovedstaden
Address: Dyrehavevej 29
City: Hilleroed
Postcode: 3400
Country: Denmark

Scientific contact point

Organisation: Nordsjaellands Hospital
Contact name: Department of Ear, Nose and Throat, Nordsjællands Hospital, Denmark

Public contact point

Organisation: Nordsjaellands Hospital
Contact name: Department of Ear, Nose and Throat, Nordsjællands Hospital, Denmark

Third parties 1

Organisation	City, country	Duties
Frederiksberg Hospital ORG-100028217	Frederiksberg, Denmark	On site monitoring

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Denmark	Ongoing, recruiting	88	2
Rest of world	—	0	—

Investigational sites

Denmark

2 sites · Ongoing, recruiting

Hillerod Hospital

Department of Otolaryngology, Head and Neck Surgery, Nordsjællands Hospital, Dyrehavevej 29, 3400, Hilleroed

Zealand University Hospital

Department of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Lykkebaekvej 1, 4600, Koege

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Denmark	2025-06-12		2025-06-12

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	Protocol	2
Summary of Product Characteristics (SmPC) (for publication)	Summary of product characteristics	1

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-06-07	Denmark	Acceptable 2023-08-21	2023-08-28
2	SUBSTANTIAL MODIFICATION	SM-4	2025-10-22	Denmark	Acceptable 2025-10-24	2025-10-26
3	NON SUBSTANTIAL MODIFICATION	NSM-1	2026-02-03	Denmark	Acceptable 2025-10-24	2026-02-03