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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR PROTONIX


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All Clinical Trials for PROTONIX

Trial IDTitleStatusSponsorPhaseStart DateSummary
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 5 of 5 entries

Clinical Trial Conditions for PROTONIX

Condition Name

102220-101234567891011HealthyHealthy AdultsEsophagitisGastroesophageal Reflux[disabled in preview]
Condition Name for PROTONIX
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 RefluxMalnutritionHemorrhageGastrointestinal Hemorrhage[disabled in preview]
Condition MeSH for PROTONIX
Intervention Trials
Gastroesophageal Reflux 5
Malnutrition 3
Hemorrhage 2
Gastrointestinal Hemorrhage 2
[disabled in preview] 0
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Clinical Trial Locations for PROTONIX

Trials by Country

+
Trials by Country for PROTONIX
Location Trials
United States 21
Canada 9
India 6
United Kingdom 1
Hungary 1
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Trials by US State

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

Clinical Trial Phase

24.1%10.3%6.9%58.6%024681012141618Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for PROTONIX
Clinical Trial Phase Trials
Phase 4 7
Phase 3 3
Phase 2/Phase 3 2
[disabled in preview] 17
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Clinical Trial Status

66.7%10.0%10.0%13.3%02468101214161820CompletedWithdrawnTerminated[disabled in preview]
Clinical Trial Status for PROTONIX
Clinical Trial Phase Trials
Completed 20
Withdrawn 3
Terminated 3
[disabled in preview] 4
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Clinical Trial Sponsors for PROTONIX

Sponsor Name

trials011223344Assiut UniversityWyeth is now a wholly owned subsidiary of PfizerMirati Therapeutics Inc.[disabled in preview]
Sponsor Name for PROTONIX
Sponsor Trials
Assiut University 2
Wyeth is now a wholly owned subsidiary of Pfizer 2
Mirati Therapeutics Inc. 2
[disabled in preview] 4
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Sponsor Type

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

Introduction to Protonix

Protonix, also known as pantoprazole sodium, is a proton pump inhibitor (PPI) used to treat various gastrointestinal conditions, including gastroesophageal reflux disease (GERD) and erosive esophagitis (EE). Here, we will delve into recent clinical trials, market analysis, and future projections for Protonix.

Clinical Trials Update

Pediatric Indication

A recent supplemental new drug application (NDA 20988/S-070) submitted by Wyeth sought approval for the use of Protonix IV in pediatric patients for the short-term intravenous treatment of GERD associated with EE. This submission included data from Study B1791089, an open-label, pharmacokinetic (PK) and safety study of IV pantoprazole in pediatric subjects aged 1 to 16 years. Additionally, a population pharmacokinetics (PopPK) model was used to compare exposure between pediatric subjects and adults. The study also included a retrospective cohort study using electronic health records (EHR) to assess the safety of pantoprazole IV in pediatric patients aged 1 month to less than 2 years[1].

Safety and Efficacy

The clinical trials demonstrated that the most common adverse reactions in adults included headache, diarrhea, nausea, abdominal pain, and vomiting. For pediatric patients, the safety profile was generally consistent with that observed in adults, supporting the use of Protonix IV in this age group[1].

Market Analysis

Global Market Size and Growth

The global proton pump inhibitors (PPIs) market, which includes Protonix, is expected to experience significant growth. By 2024, the market is projected to reach USD 12.70 billion and is anticipated to grow at a compound annual growth rate (CAGR) of 5.14% to reach USD 16.32 billion by 2029[2].

Regional Market Performance

North America currently holds the largest market share in the PPIs market, while the Asia Pacific region is expected to be the fastest-growing market during the forecast period. Emerging markets with growing middle classes, improving healthcare infrastructure, and rising disposable incomes are driving the demand for PPIs like Protonix[2][3].

Key Players and Market Dynamics

The PPIs market is moderately fragmented, with major players including AstraZeneca, Bayer AG, Cadila Pharmaceuticals, GlaxoSmithKline PLC, and Pfizer. These companies are focusing on aggressive marketing, awareness programs, and the launch of generic versions to capture market share. For instance, Dr. Reddy's Laboratories Ltd. launched a generic version of lansoprazole in 2021, which has contributed to market growth[2].

Market Projections

Future Growth Drivers

The growth of the PPIs market, including Protonix, is driven by several factors:

  • Increasing Demand for Effective Treatments: The rising incidence of gastrointestinal disorders such as GERD and EE is driving the demand for effective acid-suppressing medications like Protonix[3].
  • Technological Advancements: Improvements in formulation technologies and the development of novel drug delivery systems are enhancing the efficacy and safety of PPIs. Additionally, the use of artificial intelligence and big data analytics is optimizing treatment outcomes[3].
  • Generic Drug Launches: The introduction of generic versions of PPIs is expected to continue driving market growth by providing more affordable treatment options[2].

Challenges and Considerations

Despite the positive growth projections, the market faces some challenges:

  • COVID-19 Impact: The COVID-19 pandemic has had a mixed impact on the PPIs market. While it initially reduced demand due to concerns about increased risk of COVID-19 infection and poor outcomes in patients taking PPIs, the market is expected to recover as the pandemic subsides[2].
  • Regulatory and Safety Concerns: Continuous monitoring of safety outcomes and regulatory approvals are crucial for the sustained growth of the PPIs market. For example, the FDA's approval process for new indications, such as the recent approval for pediatric use, is vital for market expansion[1].

Key Takeaways

  • Clinical Trials: Recent clinical trials have supported the approval of Protonix IV for pediatric patients, expanding its use in treating GERD and EE.
  • Market Size and Growth: The global PPIs market is projected to grow significantly, with North America holding the largest market share and the Asia Pacific region expected to be the fastest-growing.
  • Key Players: Major pharmaceutical companies are driving market growth through aggressive marketing, generic launches, and technological advancements.
  • Future Growth Drivers: Increasing demand for effective treatments, technological advancements, and generic drug launches are key drivers of market growth.

FAQs

What is the current market size of the proton pump inhibitors market?

The proton pump inhibitors market is expected to reach USD 12.70 billion in 2024[2].

Which region is the fastest-growing market for proton pump inhibitors?

The Asia Pacific region is estimated to be the fastest-growing market for proton pump inhibitors during the forecast period[2].

What are the major factors driving the growth of the proton pump inhibitors market?

The growth is driven by increasing demand for effective treatments, technological advancements, and the launch of generic versions[2][3].

Which companies are major players in the proton pump inhibitors market?

Major players include AstraZeneca, Bayer AG, Cadila Pharmaceuticals, GlaxoSmithKline PLC, and Pfizer[2].

How has the COVID-19 pandemic impacted the proton pump inhibitors market?

The pandemic initially reduced demand due to safety concerns but is expected to recover as the pandemic subsides[2].

Cited Sources

  1. FDA: NDA 20988/S-070 Protonix IV (Pantoprazole Sodium) Integrated Review Template, version 4.0 (11/1/23)[1].
  2. Mordor Intelligence: Proton Pump Inhibitors Market - Size, Share & Analysis[2].
  3. Future Market Insights: Proton Pump Inhibitors Market Share & Forecast by 2033[3].

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