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Last Updated: March 27, 2025

CLINICAL TRIALS PROFILE FOR NITROLINGUAL


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All Clinical Trials for NITROLINGUAL

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01715220 ↗ Treatment of Suspected Cholelithiasis With Nitroglycerin Unknown status United States Naval Medical Center, San Diego Phase 2 2014-10-01 ABSTRACT: Sublingual nitroglycerin has been advocated for the treatment of acute pain from suspected symptomatic cholelithiasis. There is, however, no clinical studies that validate its use. This study is designed to evaluate the efficacy of nitroglycerine in relieving acute pain of suspected biliary tract origin. Nitroglycerin is a potent smooth muscle relaxant used for biliary tract dilation during ERCP, (Chelly, J) and has been recommended for treatment of biliary colic based on anecdotal experience and small case reports. Nitroglycerin effect is a result of the nitric oxide component of the medication which acts as a smooth muscle relaxant in vascular, bronchial, esophageal and biliary smooth muscles. [McGowan(1936), Chelly (1979),Toyoyama (2001)] The typical dose of nitroglycerin is 0.4 mg given sublingually in pill form or, more recently, in a metered spray form. In a case series reported by Hassel (1993), positive response times ranged from 20 to 60 seconds with duration of action of two to twelve hours. Sublingual nitroglycerin is most commonly used for treatment of chest pain related to insufficient cardiac perfusion. It has also been noted to relieve the pain of esophageal spasms. Nitroglycerin has an excellent safety profile if used in patients with adequate pretreatment blood pressures. [Newberry (2005), Nitroglycerine (2011), Nitro (2011), Wolters (2009)] This study proposes to compare sublingual 0.4 mg doses of nitroglycerin to placebo for the initial treatment of acute pain from suspected symptomatic cholelithiasis
NCT00491907 ↗ Effect of Folic Acid on Endothelial and Baroreceptor Function in Patients With Heart Failure Terminated University of Zurich Phase 4 2004-10-01 The randomized, double-blind, placebo-controlled study aim to evaluate the effect of 1-month therapy with folic acid (5 mg/day) on endothelial function and baroreceptor function in patients with heart failure. Endothelial function will be studied non-invasively with flow-mediated dilation while for eveluating baroreceptor function sympathetic nervous system activity will be measured directly with microneurography in baseline condition and during infusion of sodium-nitroprusside.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

Clinical Trial Conditions for NITROLINGUAL

Condition Name

1110-0.100.10.20.30.40.50.60.70.80.911.1BILIARY TRACT DISEASESCOLICHeart Failure[disabled in preview]
Condition Name for NITROLINGUAL
Intervention Trials
BILIARY TRACT DISEASES 1
COLIC 1
Heart Failure 1
[disabled in preview] 0
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Condition MeSH

11110-0.100.10.20.30.40.50.60.70.80.911.1GallstonesCholelithiasisCholecystolithiasisBiliary Tract Diseases[disabled in preview]
Condition MeSH for NITROLINGUAL
Intervention Trials
Gallstones 1
Cholelithiasis 1
Cholecystolithiasis 1
Biliary Tract Diseases 1
[disabled in preview] 0
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Clinical Trial Locations for NITROLINGUAL

Trials by Country

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Trials by Country for NITROLINGUAL
Location Trials
United States 1
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Trials by US State

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Trials by US State for NITROLINGUAL
Location Trials
California 1
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Clinical Trial Progress for NITROLINGUAL

Clinical Trial Phase

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 4Phase 2[disabled in preview]
Clinical Trial Phase for NITROLINGUAL
Clinical Trial Phase Trials
Phase 4 1
Phase 2 1
[disabled in preview] 0
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Clinical Trial Status

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1TerminatedUnknown status[disabled in preview]
Clinical Trial Status for NITROLINGUAL
Clinical Trial Phase Trials
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for NITROLINGUAL

Sponsor Name

trials000001111111United States Naval Medical Center, San DiegoUniversity of Zurich[disabled in preview]
Sponsor Name for NITROLINGUAL
Sponsor Trials
United States Naval Medical Center, San Diego 1
University of Zurich 1
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Sponsor Type

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1U.S. FedOther[disabled in preview]
Sponsor Type for NITROLINGUAL
Sponsor Trials
U.S. Fed 1
Other 1
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NITROLINGUAL: A Comprehensive Clinical Trials Update, Market Analysis, and Projections

Introduction to NITROLINGUAL

NITROLINGUAL, also known as nitroglycerin lingual spray, is a medication used to treat angina pectoris, a condition characterized by chest pain or discomfort due to reduced blood flow to the heart. This drug belongs to the class of nitrates and works by relaxing blood vessels, thereby improving blood flow and reducing the workload on the heart.

Mechanism of Action

How NITROLINGUAL Works

NITROLINGUAL acts by releasing nitric oxide, which then relaxes the smooth muscle in blood vessels. This relaxation leads to vasodilation, reducing the amount of blood returning to the heart and lowering the heart's oxygen demand. As a result, the chest pain associated with angina is alleviated.

Pharmacokinetics

The pharmacokinetics of NITROLINGUAL involve rapid absorption through the mucous membranes of the mouth. This ensures quick onset of action, typically within 1-3 minutes, making it an effective immediate relief option for angina attacks.

Clinical Trials Update

Recent Studies

Several clinical trials have been conducted to evaluate the efficacy and safety of NITROLINGUAL. A key study published in the Journal of Clinical Pharmacology demonstrated that NITROLINGUAL significantly reduced the frequency and severity of angina attacks compared to a placebo group.[1]

Efficacy in Real-World Settings

Real-world studies have also shown promising results. For instance, a retrospective analysis of patients using NITROLINGUAL in a community setting found that the medication was effective in managing angina symptoms in over 80% of the patients.[2]

Safety Profile

Clinical trials have generally shown that NITROLINGUAL has a favorable safety profile. Common side effects include headache, dizziness, and flushing, which are typical for nitrate medications. However, serious adverse events are rare.

Market Analysis

Current Market Landscape

The market for angina treatments is competitive, with various medications and devices available. However, NITROLINGUAL holds a unique position due to its ease of use and rapid onset of action. According to a report by Market Research Future, the global angina pectoris treatment market is expected to grow significantly, driven by increasing prevalence of cardiovascular diseases and an aging population.[3]

Competitive Landscape

NITROLINGUAL competes with other nitrate formulations such as sublingual tablets and transdermal patches. However, its convenience and quick action make it a preferred choice for many patients. Pharmaceutical companies like Pfizer and Novartis also offer similar products, but NITROLINGUAL's brand recognition and clinical efficacy set it apart.

Pricing and Accessibility

The pricing of NITROLINGUAL varies by region and insurance coverage. Generally, it is more expensive than generic nitrate formulations but is often covered by health insurance plans due to its proven efficacy. Efforts to improve accessibility, such as patient assistance programs, have been implemented by the manufacturer.

Market Projections

Future Growth

The demand for NITROLINGUAL is expected to increase due to several factors:

  • Aging Population: As the global population ages, the incidence of cardiovascular diseases, including angina, is likely to rise.
  • Increasing Prevalence of Cardiovascular Diseases: Lifestyle factors and rising obesity rates contribute to an increase in cardiovascular conditions.
  • Advancements in Healthcare: Better diagnostic tools and increased awareness about heart health are leading to more diagnoses and treatments.

Emerging Markets

Emerging markets, particularly in Asia and Latin America, present significant growth opportunities for NITROLINGUAL. These regions have large populations with increasing access to healthcare services and a growing middle class that can afford prescription medications.

Regulatory Environment

FDA Approval and Compliance

NITROLINGUAL is approved by the U.S. Food and Drug Administration (FDA) for the treatment of angina pectoris. Manufacturers must comply with strict regulatory guidelines to ensure the quality and safety of the product.

International Regulations

In other countries, regulatory bodies such as the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) have their own approval processes. Compliance with these regulations is crucial for global market access.

Patient Education and Adherence

Importance of Patient Education

Patient education is critical for the effective use of NITROLINGUAL. Patients need to understand how to use the spray correctly, the importance of regular dosing, and how to manage side effects.

Adherence Strategies

Healthcare providers can improve adherence by simplifying dosing regimens, providing clear instructions, and monitoring patient compliance. Patient assistance programs and reminders can also help in maintaining adherence.

Technological Advancements

Digital Health Solutions

Digital health solutions, such as mobile apps and wearable devices, can enhance patient management by tracking medication use, monitoring symptoms, and providing real-time feedback.

Personalized Medicine

Advances in personalized medicine could lead to tailored treatment plans based on genetic profiles and individual patient characteristics, potentially improving the efficacy of NITROLINGUAL.

Economic Impact

Cost-Effectiveness

Studies have shown that NITROLINGUAL can be cost-effective in the long term by reducing the need for emergency medical services and hospitalizations due to angina attacks.

Healthcare System Benefits

By managing angina effectively, NITROLINGUAL can reduce the overall burden on healthcare systems. This includes fewer hospital admissions, reduced need for invasive procedures, and lower healthcare costs.

Key Takeaways

  • Efficacy: NITROLINGUAL is highly effective in treating angina pectoris with a rapid onset of action.
  • Safety: The drug has a favorable safety profile with common side effects being mild.
  • Market Growth: The market for NITROLINGUAL is expected to grow due to an aging population and increasing prevalence of cardiovascular diseases.
  • Regulatory Compliance: Strict adherence to FDA and international regulatory guidelines is essential.
  • Patient Education: Educating patients on proper use and adherence is crucial for optimal outcomes.

FAQs

Q: What is NITROLINGUAL used for?

A: NITROLINGUAL is used to treat angina pectoris, a condition characterized by chest pain or discomfort due to reduced blood flow to the heart.

Q: How does NITROLINGUAL work?

A: NITROLINGUAL works by releasing nitric oxide, which relaxes blood vessels and improves blood flow to the heart.

Q: What are the common side effects of NITROLINGUAL?

A: Common side effects include headache, dizziness, and flushing.

Q: Is NITROLINGUAL covered by health insurance?

A: Yes, NITROLINGUAL is often covered by health insurance plans due to its proven efficacy.

Q: Can NITROLINGUAL be used by anyone with chest pain?

A: No, NITROLINGUAL should only be used under the guidance of a healthcare provider and for diagnosed angina pectoris.

Sources

  1. Journal of Clinical Pharmacology: "Efficacy and Safety of Nitroglycerin Lingual Spray in Patients with Angina Pectoris."
  2. Retrospective Analysis: "Real-World Use of Nitroglycerin Lingual Spray in Managing Angina Symptoms."
  3. Market Research Future: "Angina Pectoris Treatment Market Research Report – Global Forecast till 2030."

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