Efficacy of Glyceryl Trinitrate in Esophageal Food Impaction: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase 2 Trial

The primary objective of this multicenter, double-blind, randomized, placebo-controlled, Phase 2 clinical trial is to evaluate the **efficacy** of treatment with nitroglycerin for **esophageal food impaction** (EFI). This condition involves the obstruction of the esophagus by ingested food, which can lead to significant discomfort and potential complications if not promptly resolved. The clinical relevance of this study lies in determining whether nitroglycerin, administered as a sublingual tablet, can effectively alleviate this obstruction, thereby providing a non-invasive treatment option for patients experiencing EFI.

The clinical trial focuses on evaluating the efficacy of treatment with nitroglycerin for **esophageal food impaction**. The study population includes both male and female participants aged 18 years and older. The trial does not involve a vulnerable population. Participants were selected based on their presentation consistent with esophageal food impaction for a minimum duration of one hour and their ability to provide informed consent. The sponsor has not provided information regarding the total number of participants. No specific lifestyle considerations such as diet, physical activity, or habits have been highlighted as relevant to the study. Key inclusion criteria include an age above 18 years and a confirmed presentation of esophageal food impaction. The trial does not specify any exclusion criteria in the provided data.

The clinical trial is designed to evaluate the efficacy of **nitroglycerin** for the treatment of **esophageal food impaction**. This study is a multicenter, double-blind, randomized, placebo-controlled, Phase 2 trial. The trial is expected to commence recruitment on October 1, 2023, and conclude by October 1, 2025. Participants will be randomly assigned to receive either the active treatment, **Nitroglycerin "DAK"**, in the form of sublingual tablets, or a placebo, which is a white, round, convex tablet developed to mimic the active formulation without containing the active ingredient.

The trial will include several study visits, beginning with a screening visit to confirm eligibility based on the inclusion criteria, which require participants to be over 18 years of age, present with symptoms consistent with esophageal food impaction for at least one hour, and provide informed consent. Following the screening, participants will undergo randomization and receive their assigned treatment. The primary endpoint of the study is the number of patients achieving resolution of esophageal food impaction without the need for endoscopic removal when treated with nitroglycerin compared to placebo.

Participants will be involved in the study for a maximum treatment period of one day, as the intervention is designed to address acute symptoms. Follow-up visits will be scheduled to monitor the resolution of symptoms and any adverse events. The end-of-study visit will occur after the treatment period to assess the final outcomes and collect data on the primary endpoint. Conditions that may lead to early termination from the study include withdrawal of consent, occurrence of significant adverse events, or any other medical reasons deemed necessary by the investigator.

The clinical trial involves the administration of **Nitroglycerin "DAK"**, a sublingual tablet containing **glyceryl trinitrate** as the active substance. This pharmaceutical form is designed for **oral use** and is classified under the ATC code **C01DA02**. The medication is produced by Orifarm Healthcare A/S and is authorized in Denmark. The maximum daily dose is 1 mg, with a total treatment period of one day. The sublingual tablet is intended to dissolve under the tongue, allowing for rapid absorption into the bloodstream. Compliance with the dosing schedule is monitored to ensure adherence to the treatment protocol.

The study also includes a **placebo** group, utilizing a 6 mm convex, white, round tablet developed at the Capital Region Pharmacy in Denmark. This placebo is identical in appearance to a marketed SAD tablet but lacks any active ingredient. The placebo serves as a comparator to evaluate the efficacy of the experimental treatment. No specific documentation for the pharmaceutical development of the placebo is provided, as it is designed to mimic the physical characteristics of the active treatment without therapeutic effects.

The efficacy of the treatment with **nitroglycerin** for esophageal food impaction (EFI) will be assessed in a multicenter, double-blind, randomized, placebo-controlled, Phase 2 clinical trial. The primary endpoint for evaluating efficacy is the number of patients experiencing resolution of EFI without the need for endoscopic removal when treated with nitroglycerin compared to those treated with a placebo. This endpoint will provide a direct measure of the treatment's effectiveness in resolving EFI.