CLINICAL TRIALS PROFILE FOR PROSTIN VR PEDIATRIC

All Clinical Trials for Prostin Vr Pediatric

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00141895 ↗	A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death	Terminated	American University of Beirut Medical Center	Phase 3	2004-09-01	Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance to effect the medical termination of pregnancy in the second trimester, either alone or after pretreatment with mifepristone. The primary reasons for this prompt incorporation into standard practice include its low cost and the lack of stringent storage requirements. Vaginal administration seems to be more efficacious than when given orally. The use of sublingual misoprostol for first trimester abortions has been extensively investigated as evidenced by the large number of publications comparing sublingual to other routes of misoprostol for first trimester pregnancy termination, on the assumption that the sublingual route would have a similar efficacy of the vaginal route. In addition, the sublingual route would combine an easier administration with the added advantage of no restriction of mobility after administration. There has been no previous report in the literature comparing the use of misoprostol given sublingually to that given vaginally for the second trimester termination following intrauterine fetal death. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually.
NCT00545194 ↗	Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess	Completed	Institut National de la Santé Et de la Recherche Médicale, France	Phase 3	2002-01-01	The aim of this study is to compare two different preparation
NCT01635439 ↗	Prostin and Propess in Induction of Labor	Completed	North West Armed Forces Hospital	Phase 3	2010-12-01	The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).

Clinical Trial Conditions for Prostin Vr Pediatric

Condition Name

Condition Name for Prostin Vr Pediatric
Intervention	Trials
IUCD Complication	2
Cost	1
Postmenopausal Bleeding	1

Condition MeSH

Condition MeSH for Prostin Vr Pediatric
Intervention	Trials
Hemorrhage	1
Obstetric Labor Complications	1
Labor Pain	1

Clinical Trial Locations for Prostin Vr Pediatric

Trials by Country

Trials by Country for Prostin Vr Pediatric
Location	Trials
Egypt	3
Singapore	2
Saudi Arabia	1
United Kingdom	1
France	1

Clinical Trial Progress for Prostin Vr Pediatric

Clinical Trial Phase

Clinical Trial Phase for Prostin Vr Pediatric
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Prostin Vr Pediatric
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	3
Recruiting	2

Clinical Trial Sponsors for Prostin Vr Pediatric

Sponsor Name

Sponsor Name for Prostin Vr Pediatric
Sponsor	Trials
Aswan University Hospital	3
University of Malaya	1
Yong Loo Lin School of Medicine	1

Sponsor Type

Sponsor Type for Prostin Vr Pediatric
Sponsor	Trials
Other	22

Prostin VR Pediatric: Clinical Trials, Market Analysis, and Projections

Introduction

Prostin VR Pediatric, containing alprostadil, is a crucial medication for maintaining the patency of the ductus arteriosus in neonates with congenital heart defects. This article delves into the clinical trials, market analysis, and projections for this vital drug.

Clinical Indications and Usage

Prostin VR Pediatric is indicated for palliative therapy to maintain the ductus arteriosus patency until corrective or palliative surgery can be performed in neonates with congenital heart defects such as pulmonary atresia, pulmonary stenosis, and tetralogy of Fallot[1][2][4].

Clinical Trials and Efficacy

Clinical trials for Prostin VR Pediatric have primarily focused on its efficacy in maintaining ductus arteriosus patency and its safety profile in neonates. The drug is administered via continuous IV infusion, and its efficacy is monitored through improvements in blood oxygenation and systemic blood pressure[2][4].

• Dosing and Administration: The initial dose is typically 0.05-0.1 mcg/kg/min, which can be adjusted to maintain the lowest effective dose. In cases where transport of the infant is necessary, doses as low as 0.005 mcg/kg/min have been used successfully[2].
• Adverse Reactions: Common adverse reactions include apnea, fever, flushing, bradycardia, and hypotension. Apnea is particularly significant, occurring in about 10-12% of neonates, especially those weighing less than 2 kg at birth[1][2][4].

Market Analysis

The market for Prostin VR Pediatric is part of the broader pediatric pharmaceutical market, which is driven by several key factors:

• Increasing Prevalence of Pediatric Diseases: The rising incidence of infectious and chronic diseases in the pediatric population is a significant driver. Conditions such as congenital heart defects necessitate the use of drugs like Prostin VR Pediatric[3].
• Research and Development Investments: Pharmaceutical companies are investing heavily in pediatric clinical trials, which includes the development of drugs like Prostin VR Pediatric. This investment is crucial for addressing the unmet healthcare needs of the pediatric population[3].

Market Size and Projections

The global pediatric clinical trials market, which includes drugs like Prostin VR Pediatric, is projected to grow significantly:

• Current Market Size: The global pediatric clinical trials market was valued at USD 17.37 billion in 2024[3].
• Projected Growth: This market is expected to reach around USD 27.65 billion by 2033, expanding at a CAGR of 5.3% from 2024 to 2033[3].

Key Market Segments

The pediatric clinical trials market is segmented based on several factors:

• Phase II Trials: This segment dominated the market in 2023, accounting for more than 32% of the global revenue. Phase II trials are critical for investigating the efficacy and safety of interventions in children[3].
• Therapeutic Areas: The oncology segment accounted for the second-largest revenue share in 2023, highlighting the diverse therapeutic areas being addressed in pediatric clinical trials[3].

Challenges and Considerations

The use of Prostin VR Pediatric comes with several challenges and considerations:

• Ethanol Content: Each 1 ml vial of Prostin VR contains 790 mg of anhydrous ethanol, which can affect children significantly. For example, administering 0.576 ml to a 2 kg infant could result in a blood alcohol concentration of about 37.9 mg/100 ml[2].
• Long-term Infusion Risks: Prolonged therapy (>120 hours) requires monitoring for antral hyperplasia, gastric outlet obstruction, and cortical proliferation of the long bones. These risks must be weighed against the benefits of the drug[1][2][4].

Patient Counseling and Monitoring

Given the potential adverse reactions, it is crucial to monitor respiratory status, arterial pressure, blood oxygenation, and blood pH during treatment. Ventilatory assistance should be immediately available due to the risk of apnea[1][2][4].

Conclusion

Prostin VR Pediatric is a vital drug for neonates with congenital heart defects, and its market is influenced by the broader trends in pediatric clinical trials. As the global pediatric clinical trials market grows, the demand for drugs like Prostin VR Pediatric is expected to increase, driven by the need for effective and safe treatments for pediatric conditions.

Key Takeaways

• Clinical Indications: Prostin VR Pediatric is used to maintain ductus arteriosus patency in neonates with congenital heart defects.
• Dosing and Administration: The drug is administered via continuous IV infusion, with initial doses ranging from 0.05-0.1 mcg/kg/min.
• Adverse Reactions: Common adverse reactions include apnea, fever, and hypotension.
• Market Growth: The global pediatric clinical trials market is projected to reach USD 27.65 billion by 2033.
• Challenges: The drug contains significant amounts of ethanol and requires careful monitoring for long-term infusion risks.

FAQs

Q: What is the primary indication for Prostin VR Pediatric? A: Prostin VR Pediatric is indicated for palliative therapy to maintain the patency of the ductus arteriosus in neonates with congenital heart defects.

Q: How is Prostin VR Pediatric administered? A: The drug is administered via continuous IV infusion into a large vein or through an umbilical artery catheter.

Q: What are the common adverse reactions associated with Prostin VR Pediatric? A: Common adverse reactions include apnea, fever, flushing, bradycardia, and hypotension.

Q: Why is ventilatory assistance important during Prostin VR Pediatric treatment? A: Ventilatory assistance is crucial due to the risk of apnea, which occurs in about 10-12% of neonates treated with the drug.

Q: What are the long-term risks associated with prolonged infusion of Prostin VR Pediatric? A: Prolonged therapy (>120 hours) can lead to antral hyperplasia, gastric outlet obstruction, and cortical proliferation of the long bones.

Sources

1. PROSTIN VR PEDIATRIC Prescription & Dosage Information - MPR
2. PROSTIN VR Alprostadil 0.5 mg/ml concentrate Reference market - Pfizer
3. Pediatric Clinical Trials Market Size to Hit USD 27.65 Billion by 2033 - Biospace
4. PROSTIN VR® (alprostadil) - Pfizer Medical Information - US