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Last Updated: June 14, 2025

CLINICAL TRIALS PROFILE FOR LANOXIN PEDIATRIC


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All Clinical Trials for Lanoxin Pediatric

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00578617 ↗ Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial Completed Abbott Medical Devices N/A 2006-09-01 The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
NCT00578617 ↗ Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial Completed Duke Clinical Research Institute N/A 2006-09-01 The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
NCT00578617 ↗ Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial Completed St. Jude Medical N/A 2006-09-01 The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
NCT00578617 ↗ Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial Completed Mayo Clinic N/A 2006-09-01 The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
NCT00723424 ↗ Drug Interaction Study - Effect of AZD5672 on the Pharmacokinetics of Digoxin Completed AstraZeneca Phase 1 2008-07-01 The purpose of the study is to examine the effect of AZD5672 (dosed to steady state) on the pharmacokinetics of digoxin (single dose administration).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lanoxin Pediatric

Condition Name

Condition Name for Lanoxin Pediatric
Intervention Trials
Healthy 7
Atrial Fibrillation 2
Acute Alcoholic Hepatitis 1
Heart Failure 1
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Condition MeSH

Condition MeSH for Lanoxin Pediatric
Intervention Trials
Atrial Fibrillation 2
Diabetes Mellitus, Type 2 1
Alcohol-Induced Disorders 1
Neoplasms 1
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Clinical Trial Locations for Lanoxin Pediatric

Trials by Country

Trials by Country for Lanoxin Pediatric
Location Trials
United States 20
Sweden 1
China 1
Germany 1
Netherlands 1
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Trials by US State

Trials by US State for Lanoxin Pediatric
Location Trials
Texas 2
Connecticut 2
Ohio 2
Illinois 2
California 2
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Clinical Trial Progress for Lanoxin Pediatric

Clinical Trial Phase

Clinical Trial Phase for Lanoxin Pediatric
Clinical Trial Phase Trials
Phase 4 1
Phase 2 2
Phase 1 12
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Clinical Trial Status

Clinical Trial Status for Lanoxin Pediatric
Clinical Trial Phase Trials
Completed 13
Recruiting 3
Not yet recruiting 1
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Clinical Trial Sponsors for Lanoxin Pediatric

Sponsor Name

Sponsor Name for Lanoxin Pediatric
Sponsor Trials
AstraZeneca 2
Bristol-Myers Squibb 2
Alexion Pharmaceuticals 1
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Sponsor Type

Sponsor Type for Lanoxin Pediatric
Sponsor Trials
Industry 17
Other 12
NIH 1
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Lanoxin Pediatric: Clinical Trials, Market Analysis, and Projections

Introduction to Lanoxin Pediatric

Lanoxin, also known as digoxin, is a medication used to treat heart failure and certain types of irregular heartbeat. When administered to pediatric patients, it is crucial to understand the specific dosing, safety, and efficacy of this drug.

Clinical Trials and Safety Profile

Pharmacokinetics and Safety in Infants

A significant clinical trial is underway to characterize the pharmacokinetics and safety of enteral digoxin in infants with single ventricle congenital heart disease (CHD). This study, conducted by the Pediatric Trials Network (PTN), aims to enroll up to 48 infants and provide critical data on how digoxin is metabolized and its safety profile in this vulnerable population[4].

Dosing Regimens

For pediatric patients, the dosing of Lanoxin is carefully tailored based on age, body weight, and renal function. For patients between 5 to 10 years old, the total oral loading dose is 20–45 mcg/kg, while for those over 10 years old, it is 10–15 mcg/kg. Maintenance doses are adjusted based on lean body weight, renal function, age, and concomitant medications[1].

Monitoring and Toxicity

Monitoring for signs and symptoms of digoxin toxicity is essential. Serum digoxin levels should be checked regularly, with levels below 0.5 ng/mL indicating diminished efficacy and levels above 2 ng/mL associated with increased toxicity without additional benefit[1].

Market Analysis of Pediatric Drugs

Global Market Size and Growth

The global pediatric drugs market is experiencing significant growth, projected to reach USD 363.86 billion by 2032, growing at a CAGR of 12.2% from 2023 to 2032. In 2023, the market size was valued at USD 129.13 billion, with North America leading the global market with a 37% share[5].

Market Segmentation

By Type

Respiratory disorder drugs dominate the market, holding a 39.4% market share in 2023. Other segments include treatments for infectious diseases, diabetes, and various chronic conditions[2].

By Route of Administration

The oral route of administration is the most prevalent, capturing 48.7% of the market share in 2023. This is due to the ease and convenience of oral medications, especially for pediatric patients who may resist other forms of administration[2].

By Distribution Channel

Hospital pharmacies lead the market, holding a 52.7% market share in 2023. This dominance is attributed to hospitals being primary healthcare centers for children, where specialized pediatric formulations are accurately managed and dispensed[2].

Projections and Trends

Regional Growth

North America currently dominates the pediatric drugs market, but the Asia-Pacific region is expected to grow at the highest CAGR during the forecast period. This growth is driven by an increasing pediatric population, improved healthcare access, and rising demand for pediatric drugs due to growing infectious diseases and regulatory approvals[2][5].

Innovative Treatments

There is a surge in the development of innovative pediatric treatments, including new formulations of existing drugs, gene therapies, and child-friendly medications. These innovations aim to improve compliance and outcomes, further driving the market growth[2].

Regulatory Initiatives

Strict regulations requiring pediatric clinical studies for specific treatments and medications are also driving the market. Increasing clinical trial operations in developing countries and rising awareness of pediatric medicines are additional factors contributing to the growth of the pediatric drugs market[3].

Key Takeaways

  • Clinical Trials: Ongoing studies like the PTN digoxin study are crucial for understanding the pharmacokinetics and safety of Lanoxin in pediatric patients, especially those with complex heart conditions.
  • Market Growth: The pediatric drugs market is projected to grow significantly, driven by increasing demand, innovative treatments, and regulatory initiatives.
  • Regional Focus: North America currently leads the market, but the Asia-Pacific region is expected to experience rapid growth due to demographic and healthcare factors.
  • Distribution Channels: Hospital pharmacies play a critical role in the distribution and management of pediatric medications, ensuring safety and efficacy.

FAQs

What is the primary use of Lanoxin in pediatric patients?

Lanoxin, or digoxin, is primarily used to treat heart failure and certain types of irregular heartbeat in pediatric patients.

How is the dosing of Lanoxin adjusted for pediatric patients?

The dosing of Lanoxin for pediatric patients is adjusted based on age, body weight, and renal function. For example, patients between 5 to 10 years old receive a total oral loading dose of 20–45 mcg/kg, while those over 10 years old receive 10–15 mcg/kg[1].

What are the key factors driving the growth of the pediatric drugs market?

The growth of the pediatric drugs market is driven by increasing research and development investments, rising prevalence of infectious and chronic diseases, and strict regulations requiring pediatric clinical studies. Additionally, innovative treatments and improved healthcare access in developing regions contribute to this growth[2][3].

Which region is expected to grow the fastest in the pediatric drugs market?

The Asia-Pacific region is expected to grow the fastest during the forecast period due to an increasing pediatric population, improved healthcare access, and rising demand for pediatric drugs[2][5].

What role do hospital pharmacies play in the pediatric drugs market?

Hospital pharmacies lead the market for pediatric drugs, capturing a significant market share. They are crucial for accurately managing and dispensing specialized pediatric formulations, ensuring safety and efficacy[2].

Sources

  1. LANOXIN INJECTION PEDIATRIC Prescription & Dosage Information - EMPR
  2. Pediatric Drugs Market Growth Analysis | CAGR 12.7% - Market.US
  3. Pediatric Clinical Trials Market Size to Hit USD 27.65 Billion by 2033 - BioSpace
  4. Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle CHD - PediatricTrials.org
  5. Pediatric Drugs Market Size to Garner Around USD 363.86 Billion by 2032 - BioSpace
Last updated: 2025-01-02

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