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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR PROTONIX IV


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All Clinical Trials for PROTONIX IV

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00699361 ↗ Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure Withdrawn Johann Wolfgang Goethe University Hospital Phase 3 2008-08-01 Recently literature revealed facts, that show H+/K+ ATPase expression is not limited tot he stomach. H+/K+ ATPase was also found in smooth muscle cells and in other tissues (McCabe, R.D. et al., Am J Physiol. 1992). For myocard a localisation is only proven for rats yet (Beisvag, V. et al., Acta Physiol Scand. 2003). Moreover biochemical hints lead us to a highly probability of a myocardial H+/K+ ATPase (Nagashima, R. et al., Jpn Heart J. 1999).
NCT00674245 ↗ Effect of Pantoprazole 40mg Daily vs Placebo on Power Spectral Analysis of the Sleep EEG of Patients With GERD. Completed Southern Arizona VA Health Care System Phase 2/Phase 3 2008-04-01 The purpose of this research study is to determine if treatment with pantoprazole 40 mg daily versus a placebo improves sleep quality in patients with gastroesophageal reflux disease (GERD). Another purpose is to determine if treatment with pantoprazole 40 mg once daily versus a placebo improves sleep outcomes in patients with gastroesophageal reflux disease using spectral analysis of sleep electroencephalogram (EEG).
NCT00206050 ↗ Study of Intragastric pH Profile After 5 Days Pantoprazole 40 mg iv Followed by Oral Esomeprazole 40 mg po or Oral Pantoprazole 40 mg po Completed AstraZeneca Phase 4 2004-09-01 This Phase IV study is intended to compare intragastric acid suppression of oral esomeprazole (NEXIUM ® Delayed-Release Capsules) with that of oral pantoprazole (PROTONIX ® Delayed Release Tablets ), in subjects who continue to require acid-suppressive therapy following a course of intravenous (iv) pantoprazole (PROTONIX ® I.V. for Injection).
NCT00133770 ↗ Intravenous (IV) Pantoprazole in Erosive Esophagitis Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 4 2004-07-01 The aim of this study is to examine whether pantoprazole (Protonix) given through continuous intravenous infusion for 72 hours is superior to Protonix given through once a day IV injection in the treatment of erosive esophagitis.
NCT00133770 ↗ Intravenous (IV) Pantoprazole in Erosive Esophagitis Completed Emory University Phase 4 2004-07-01 The aim of this study is to examine whether pantoprazole (Protonix) given through continuous intravenous infusion for 72 hours is superior to Protonix given through once a day IV injection in the treatment of erosive esophagitis.
NCT00625274 ↗ A Randomized, Open-Label, Comparative 3-Way Treatment Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in NSAID-Using Patients Completed AstraZeneca Phase 4 2004-06-01 This study looks at controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in patients taking either non-selective or cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory drugs (NSAIDs).
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for PROTONIX IV

Condition Name

102220-101234567891011HealthyHealthy AdultsEsophagitisGastroesophageal Reflux[disabled in preview]
Condition Name for PROTONIX IV
Intervention Trials
Healthy 10
Healthy Adults 2
Esophagitis 2
Gastroesophageal Reflux 2
[disabled in preview] 0
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Condition MeSH

53220-0.500.511.522.533.544.555.5Gastroesophageal RefluxMalnutritionPsychotic DisordersMental Disorders[disabled in preview]
Condition MeSH for PROTONIX IV
Intervention Trials
Gastroesophageal Reflux 5
Malnutrition 3
Psychotic Disorders 2
Mental Disorders 2
[disabled in preview] 0
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Clinical Trial Locations for PROTONIX IV

Trials by Country

+
Trials by Country for PROTONIX IV
Location Trials
United States 21
Canada 9
India 6
Netherlands 1
Serbia 1
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Trials by US State

+
Trials by US State for PROTONIX IV
Location Trials
Missouri 4
Texas 3
Wisconsin 2
California 2
Nebraska 2
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Clinical Trial Progress for PROTONIX IV

Clinical Trial Phase

21.9%9.4%6.3%62.5%02468101214161820Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for PROTONIX IV
Clinical Trial Phase Trials
Phase 4 7
Phase 3 3
Phase 2/Phase 3 2
[disabled in preview] 20
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Clinical Trial Status

64.5%9.7%9.7%16.1%02468101214161820CompletedWithdrawnTerminated[disabled in preview]
Clinical Trial Status for PROTONIX IV
Clinical Trial Phase Trials
Completed 20
Withdrawn 3
Terminated 3
[disabled in preview] 5
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Clinical Trial Sponsors for PROTONIX IV

Sponsor Name

trials01122334455667Mirati Therapeutics Inc.AstraZenecaKremers Urban Development Company[disabled in preview]
Sponsor Name for PROTONIX IV
Sponsor Trials
Mirati Therapeutics Inc. 2
AstraZeneca 2
Kremers Urban Development Company 2
[disabled in preview] 6
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Sponsor Type

51.2%46.5%0-2024681012141618202224IndustryOtherU.S. Fed[disabled in preview]
Sponsor Type for PROTONIX IV
Sponsor Trials
Industry 22
Other 20
U.S. Fed 1
[disabled in preview] 0
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Protonix IV: Clinical Trials, Market Analysis, and Projections

Introduction to Protonix IV

Protonix IV, also known as pantoprazole sodium, is a proton pump inhibitor (PPI) used for the short-term intravenous (IV) treatment of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE). Here, we will delve into the clinical trials, market analysis, and projections for this medication.

Clinical Trials Overview

Gastroesophageal Reflux Disease (GERD) Studies

Several clinical trials have evaluated the efficacy and safety of Protonix IV in patients with GERD and a history of EE.

  • Maintenance of Gastric Acid Suppression: A multicenter, double-blind, two-period placebo-controlled study showed that Protonix IV maintained gastric acid suppression similar to oral pantoprazole in patients switched from oral to IV therapy. The study measured maximum acid output (MAO) and basal acid output (BAO) and found no significant difference between the two formulations[1].

  • Initial Treatment for GERD: Another study compared the pharmacodynamic effects of Protonix IV and Protonix Delayed-Release Tablets in patients with GERD and a history of EE. Patients treated with Protonix IV had significantly lower MAO and BAO compared to placebo and were comparable to those receiving oral tablets[1].

  • Symptom Relief: A study evaluating the clinical effects of Protonix IV and Protonix Delayed-Release Tablets in patients with acute endoscopically proven reflux esophagitis found no significant difference in symptom relief between the two formulations within the first 5 days[1].

Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome

Two studies evaluated the pharmacodynamic effects of 6-day treatment with Protonix IV in patients with Zollinger-Ellison Syndrome (ZE Syndrome). These studies showed that Protonix IV reduced acid output to target levels, maintained basal acid secretion below target levels, and did not show evidence of tolerance[1].

Pediatric Studies

A recent supplemental new drug application (NDA) included findings from Study B1791089, an open-label, pharmacokinetic (PK) and safety study of IV pantoprazole in pediatric subjects aged 1 to 16 years. The study supported the use of Protonix IV in pediatric patients 3 months of age and older for the short-term treatment of GERD associated with a history of EE[4].

Market Analysis

Global Proton Pump Inhibitors Market

The global proton pump inhibitors (PPIs) market is experiencing significant growth, driven by increasing demand for effective acid-suppressing medications.

  • Market Size and Growth: The market is currently valued at around $2.8 billion and is anticipated to reach $4.9 billion by 2033, growing at a CAGR of 5.2% during the forecast period[2].

  • Market Share: Omeprazole is the dominant player, capturing around 28.5% of the global market share in 2022. Capsules are the preferred dosage form, holding a 39.2% market share in 2022[2].

  • Regional Market: The United States leads the market with a 34.4% market share in 2023. Emerging markets, such as China, are also significant contributors, with China expected to exhibit a CAGR of 7.3% during the forecast period due to its large population and increasing healthcare expenditure[2].

Key Market Trends

  • Increasing Healthcare Expenditure: Rising healthcare spending in emerging economies is enhancing access to medical services, including diagnosis and treatment for gastrointestinal ailments, which in turn drives the demand for PPIs[2].

  • Improving Healthcare Infrastructure: Initiatives to improve healthcare infrastructure in countries like China have facilitated greater access to PPI medications, contributing to market growth[2].

  • Product Innovation: Continuous innovation in PPIs, including new formulations and delivery methods, is another key trend driving the market[2].

Market Projections

Future Market Size

The proton pump inhibitors market is projected to continue growing, driven by the increasing prevalence of gastrointestinal disorders such as GERD. By 2033, the market is expected to reach $4.9 billion, with a steady CAGR of 5.2% during the forecast period[2].

Regional Growth

  • United States: The U.S. market is expected to maintain its leading position, driven by a well-established healthcare system and high prevalence of GERD[2].

  • Emerging Markets: Countries like China will continue to exhibit high growth rates due to their large populations and increasing healthcare expenditure. China's market is expected to grow at a CAGR of 7.3% during the forecast period[2].

  • Europe: Germany and other European countries will also contribute significantly to the market growth, driven by their well-established healthcare systems and aging populations[2].

Distribution and Prescription Trends

  • Dosage Forms: Capsules remain the preferred dosage form, but IV formulations like Protonix IV are gaining traction, especially in hospital settings and for patients who cannot take oral medications[2].

  • Prescription Trends: The demand for PPIs is driven by both prescription and over-the-counter (OTC) sales. However, prescription sales are expected to dominate due to the severity of conditions like GERD and ZE Syndrome[2].

Patient Counseling and Adverse Reactions

Patient Counseling

Patients should be informed about potential adverse reactions, including injection site reactions, C. difficile-associated diarrhea, and hypomagnesemia. They should also be advised to report any signs or symptoms consistent with these conditions[1].

Adverse Reactions

Common adverse reactions include injection site reactions, upper respiratory tract infections, fever, and rash. Rare but serious adverse reactions include hypomagnesemia, mineral metabolism disorders, and severe cutaneous adverse reactions[1].

Key Takeaways

  • Clinical Efficacy: Protonix IV has been shown to be effective in maintaining gastric acid suppression and providing symptom relief in patients with GERD and a history of EE.
  • Market Growth: The global PPI market is expected to grow significantly, driven by increasing demand and improving healthcare infrastructure.
  • Regional Trends: The U.S. and emerging markets like China will be key drivers of market growth.
  • Patient Safety: Patients should be counseled on potential adverse reactions and monitored accordingly.

Frequently Asked Questions (FAQs)

1. What is Protonix IV used for?

Protonix IV is used for the short-term intravenous treatment of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE) and for pathological hypersecretion associated with Zollinger-Ellison Syndrome.

2. What are the common adverse reactions of Protonix IV?

Common adverse reactions include injection site reactions, upper respiratory tract infections, fever, and rash. Rare but serious adverse reactions include hypomagnesemia, mineral metabolism disorders, and severe cutaneous adverse reactions.

3. How does Protonix IV compare to oral pantoprazole in clinical trials?

Clinical trials have shown that Protonix IV maintains gastric acid suppression similar to oral pantoprazole and provides comparable symptom relief in patients with GERD and a history of EE.

4. What is the projected market size of the proton pump inhibitors market by 2033?

The global proton pump inhibitors market is expected to reach $4.9 billion by 2033, growing at a CAGR of 5.2% during the forecast period.

5. Which regions are expected to drive the growth of the proton pump inhibitors market?

The United States and emerging markets like China are expected to be key drivers of market growth, driven by their large populations, increasing healthcare expenditure, and improving healthcare infrastructure.

Sources:

  1. PROTONIX IV Prescription & Dosage Information - MPR - eMPR.com
  2. Proton Pump Inhibitors Market Share & Forecast by 2033 | FMI
  3. NDA 20988/S-070 Protonix IV (Pantoprazole Sodium) - FDA

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