CLINICAL TRIALS PROFILE FOR PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE

All Clinical Trials for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00365300 ↗	Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2006-09-01	To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).
NCT00300755 ↗	Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)	Completed	Nycomed	Phase 3	2006-05-01	To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
NCT00300755 ↗	Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2006-05-01	To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
NCT00312806 ↗	Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)	Completed	Takeda	Phase 3	2006-05-01	The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.
NCT00259012 ↗	Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD	Completed	Nycomed	Phase 3	2005-11-01	The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.
NCT00259012 ↗	Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2005-11-01	The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.
NCT00141817 ↗	Study Evaluating Pantoprazole in Children With GERD	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2005-08-01	The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Clinical Trial Conditions for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE

Condition Name

Condition Name for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Intervention	Trials
Gastroesophageal Reflux	7
Healthy	7
Atrial Fibrillation	1
Immunosuppression	1

Condition MeSH

Condition MeSH for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Intervention	Trials
Gastroesophageal Reflux	8
Esophagitis, Peptic	5
Malnutrition	3
Ulcer	2

Clinical Trial Locations for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE

Trials by Country

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Trials by Country for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Location	Trials
United States	111
Canada	10
India	7
Germany	4
South Africa	4

Trials by US State

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Trials by US State for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Location	Trials
Texas	7
Kentucky	6
Illinois	5
Florida	5
District of Columbia	5

Clinical Trial Progress for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	8
Phase 2	1

Clinical Trial Status

Clinical Trial Status for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	21
Not yet recruiting	1
Unknown status	1

Clinical Trial Sponsors for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE

Sponsor Name

Sponsor Name for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Sponsor	Trials
Wyeth is now a wholly owned subsidiary of Pfizer	7
Torrent Pharmaceuticals Limited	2
Ranbaxy Laboratories Limited	2

Sponsor Type

Sponsor Type for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Sponsor	Trials
Industry	22
Other	7

Pantoprazole Sodium in 0.9% Sodium Chloride Injection: Clinical Trials, Market Analysis, and Projections

Introduction

Pantoprazole Sodium in 0.9% Sodium Chloride Injection is a proton pump inhibitor (PPI) widely used for the treatment of gastroesophageal reflux disease (GERD) and pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. Here, we will delve into the clinical trials, market analysis, and projections for this medication.

Clinical Trials and Efficacy

Gastroesophageal Reflux Disease (GERD)

Clinical trials have established the efficacy of pantoprazole sodium in 0.9% sodium chloride injection for the short-term treatment (7 to 10 days) of GERD associated with a history of erosive esophagitis (EE). These trials involved adult patients and demonstrated significant reduction in gastric acid secretion, thereby alleviating symptoms of GERD[2][5].

Pathological Hypersecretion Including Zollinger-Ellison Syndrome

For pathological hypersecretory conditions, such as Zollinger-Ellison Syndrome, pantoprazole sodium in 0.9% sodium chloride injection is indicated to control acid production. Clinical trials have shown that dosages of 80 mg intravenously every 12 hours can effectively maintain acid output below 10 mEq/h, which is crucial for managing this condition[2][5].

Adverse Reactions and Safety Profile

Clinical trials have identified several adverse reactions associated with pantoprazole sodium in 0.9% sodium chloride injection. Common adverse reactions include gastrointestinal disorders such as abdominal pain, constipation, diarrhea, and nausea. Less common but serious adverse reactions include thrombophlebitis, severe cutaneous adverse reactions, cutaneous and systemic lupus erythematosus, hepatic effects, hypomagnesemia, and fundic gland polyps[1][2][4].

Dosage and Administration

Preparation and Administration

The recommended dosage for GERD is 40 mg given once daily by intravenous infusion over 15 minutes for 7 to 10 days. For pathological hypersecretion, the dosage is 80 mg intravenously every 12 hours, with the option to adjust based on individual patient needs. The solution must be prepared and administered according to specific guidelines to ensure stability and efficacy[2][4][5].

Market Analysis

Market Trends

The market for proton pump inhibitors, including pantoprazole sodium, has seen steady growth driven by increasing prevalence of GERD and other acid-related disorders. The convenience of intravenous administration, particularly in hospitalized patients who cannot tolerate oral medication, has contributed to the demand for this formulation[3].

Competitive Landscape

Pantoprazole sodium in 0.9% sodium chloride injection competes with other PPIs and acid-reducing medications. However, its specific indications and the convenience of its intravenous form make it a preferred choice in certain clinical settings. The market is also influenced by generic versions of pantoprazole, which can affect pricing and market share.

Economic Impact

The economic impact of pantoprazole sodium in 0.9% sodium chloride injection is significant, particularly in the context of hospital care. By providing a rapid and effective reduction in gastric acid secretion, it helps in reducing the length of hospital stays and associated healthcare costs. Additionally, the drug's use in managing chronic conditions like Zollinger-Ellison Syndrome contributes to long-term cost savings by preventing complications associated with these conditions.

Projections

Future Demand

Given the increasing prevalence of GERD and other acid-related disorders, the demand for pantoprazole sodium in 0.9% sodium chloride injection is expected to rise. Advances in healthcare infrastructure, especially in developing countries, will also drive the market growth.

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market dynamics of pharmaceuticals. As new clinical trials and safety data become available, regulatory bodies may update guidelines, which could impact the market. For instance, any new warnings or contraindications could affect prescribing practices.

Technological Advancements

Technological advancements in drug delivery systems and formulation improvements could enhance the efficacy and safety profile of pantoprazole sodium in 0.9% sodium chloride injection. Innovations such as more stable formulations or easier administration methods could further increase its market appeal.

Key Takeaways

• Clinical Efficacy: Pantoprazole sodium in 0.9% sodium chloride injection is effective for short-term treatment of GERD and pathological hypersecretory conditions.
• Safety Profile: The drug has a well-documented safety profile with common and serious adverse reactions identified.
• Market Trends: The market is driven by increasing prevalence of acid-related disorders and the convenience of intravenous administration.
• Economic Impact: The drug contributes to cost savings by reducing hospital stays and managing chronic conditions effectively.
• Future Projections: Demand is expected to rise with increasing healthcare infrastructure and potential technological advancements.

FAQs

Q: What are the primary indications for pantoprazole sodium in 0.9% sodium chloride injection?

A: The primary indications are short-term treatment of GERD associated with a history of erosive esophagitis and pathological hypersecretory conditions including Zollinger-Ellison Syndrome.

Q: How is pantoprazole sodium in 0.9% sodium chloride injection administered?

A: It is administered intravenously over 15 minutes, with specific dosages for GERD (40 mg once daily) and pathological hypersecretion (80 mg every 12 hours).

Q: What are the common adverse reactions associated with this drug?

A: Common adverse reactions include gastrointestinal disorders such as abdominal pain, constipation, diarrhea, and nausea.

Q: Can pantoprazole sodium in 0.9% sodium chloride injection be used for more than 10 days in GERD patients?

A: No, safety and efficacy for more than 10 days have not been demonstrated for GERD patients.

Q: How does the market for pantoprazole sodium in 0.9% sodium chloride injection look in the future?

A: The market is expected to grow due to increasing prevalence of acid-related disorders and advancements in healthcare infrastructure.

Sources

1. FDA Label: Pantoprazole Sodium in 0.9% Sodium Chloride Injection.
2. DailyMed: Pantoprazole sodium in 0.9% sodium chloride injection, solution.
3. Canadian Journal of Health Technologies: Canadian Trends in Estimated Drug Purchases and Projections.
4. Fresenius Kabi: Pantoprazole for Injection – Product Monograph.
5. Health Canada: Pantoprazole Sodium for Injection.