CLINICAL TRIALS PROFILE FOR RABEPRAZOLE SODIUM

505(b)(2) Clinical Trials for Rabeprazole Sodium

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01286194 ↗	A Study to Investigate Use Patterns and Safety in Simulated Actual Over-the-counter (OTC) Use of Rabeprazole Sodium for the Treatment of Heartburn Symptoms	Completed	Eisai Inc.		2006-04-01	This is a multi-center, open-label, all-comers OTC actual use study in pharmacy sites where the principal investigator will be a pharmacist.

All Clinical Trials for Rabeprazole Sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00125736 ↗	A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium	Completed	Eisai Co., Ltd.	Phase 4	2005-08-01	The purpose of this study is to investigate the efficacy and safety of combination use of E0671 and Rabeprazole Sodium in patients with gastric ulcer.
NCT00125736 ↗	A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium	Completed	Eisai Limited	Phase 4	2005-08-01	The purpose of this study is to investigate the efficacy and safety of combination use of E0671 and Rabeprazole Sodium in patients with gastric ulcer.
NCT00132496 ↗	Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole	Completed	Eisai Inc.	Phase 2	2005-08-01	The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16 years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement of the symptoms of GERD and to explore the relationship of symptom relief to dose received, based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.
NCT00165646 ↗	A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease	Completed	Eisai Co., Ltd.	Phase 3	2004-09-01	To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)) in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study.
NCT00165672 ↗	A Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease	Completed	Eisai Limited	Phase 3	2005-05-01	To investigate esophageal reflux condition in patients with non-erosive gastroesophageal reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week treatment with 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).
NCT00165672 ↗	A Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease	Completed	Eisai Inc.	Phase 3	2005-05-01	To investigate esophageal reflux condition in patients with non-erosive gastroesophageal reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week treatment with 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).
NCT00216450 ↗	Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults.	Completed	Janssen Cilag Pharmaceutica S.A.C.I., Greece	Phase 4	2004-10-01	The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the treatment of adult patients with Helicobacter pylori (H. pylori) infection in routine clinical practice.

Clinical Trial Conditions for Rabeprazole Sodium

Condition Name

Condition Name for Rabeprazole Sodium
Intervention	Trials
Healthy	10
Gastroesophageal Reflux	8
Gastroesophageal Reflux Disease (GERD)	5
Heartburn	3

Condition MeSH

Condition MeSH for Rabeprazole Sodium
Intervention	Trials
Gastroesophageal Reflux	20
Esophagitis, Peptic	17
Esophagitis	4
Heartburn	4

Clinical Trial Locations for Rabeprazole Sodium

Trials by Country

Trials by Country for Rabeprazole Sodium
Location	Trials
United States	137
Japan	119
India	16
Germany	13
Argentina	10

Trials by US State

Trials by US State for Rabeprazole Sodium
Location	Trials
California	7
Texas	6
Ohio	6
New York	6
Illinois	6

Clinical Trial Progress for Rabeprazole Sodium

Clinical Trial Phase

Clinical Trial Phase for Rabeprazole Sodium
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	13
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Rabeprazole Sodium
Clinical Trial Phase	Trials
Completed	43
Not yet recruiting	3
Terminated	1

Clinical Trial Sponsors for Rabeprazole Sodium

Sponsor Name

Sponsor Name for Rabeprazole Sodium
Sponsor	Trials
Eisai Inc.	14
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	6
Eisai Co., Ltd.	5

Sponsor Type

Sponsor Type for Rabeprazole Sodium
Sponsor	Trials
Industry	51
Other	6

Rabeprazole Sodium: Clinical Trials, Market Analysis, and Projections

Introduction to Rabeprazole Sodium

Rabeprazole sodium is a proton pump inhibitor (PPI) widely used to treat various gastrointestinal disorders, including gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. It works by reducing the amount of acid produced in the stomach by inhibiting the gastric H+/K+ATPase at the secretory surface of the gastric parietal cell[5].

Clinical Trials and Efficacy

FDA Approval for Pediatric Use

In 2013, the U.S. Food and Drug Administration (FDA) approved ACIPHEX Sprinkle (rabeprazole sodium) for the treatment of GERD in children aged 1 to 11 years. This approval was based on a multicenter, double-blind, parallel-group clinical trial involving 127 pediatric patients with endoscopically-proven GERD. The trial showed that 81% of patients achieved healing during the 12-week treatment period, and 90% retained healing during the subsequent 24-week extension period[1].

Adverse Events in Clinical Trials

The clinical trial for pediatric use also reported common adverse events, including cough (14%), vomiting (14%), abdominal pain (12%), diarrhea (11%), pyrexia (10%), and headache (9%). These events were observed during the 12-week treatment period[1].

Ongoing Clinical Studies

Current clinical studies are exploring the efficacy and safety of rabeprazole sodium in combination with other medications. For example, a single-center, randomized, open-label phase Ic/IIb clinical study is evaluating the efficacy and safety of rabeprazole sodium enteric-coated tablets combined with amoxicillin capsules in patients with Helicobacter pylori infection[4].

Market Analysis

Global Market Size and Growth

The global rabeprazole sodium market is projected to experience significant growth. By 2031, the market is expected to reach $845.3 million, growing at a compound annual growth rate (CAGR) of 3.7%[2]. Another forecast suggests the market will reach nearly $896.01 million by 2029, growing at a CAGR of 4.6% from 2023 to 2029[3].

Regional Market Dynamics

North America and Europe are currently the largest markets for rabeprazole sodium, driven by a well-established healthcare infrastructure, extensive insurance coverage, and high healthcare spending. The Asia Pacific region is expected to see significant growth due to the increasing prevalence of GERD and other digestive disorders[3].

Market Drivers

Several factors are driving the growth of the rabeprazole sodium market:

• High Incidence of GERD and Peptic Ulcers: The increasing prevalence of these conditions in the general population is a major driver.
• Aging Population: Older adults are more prone to gastrointestinal disorders, contributing to market growth.
• Changing Dietary Habits: Modern dietary habits are associated with a higher incidence of digestive disorders.
• Availability of Generic Versions: Lower-cost generic versions of rabeprazole sodium are expected to boost market growth[3].

Market Trends

Combination Therapies

There is a growing trend toward combination therapies in the rabeprazole sodium market. Healthcare providers are combining different drugs to create customized treatment plans that are more effective and better suited to individual patient needs. This trend is expected to continue as healthcare providers seek to optimize treatment outcomes while minimizing side effects and healthcare costs[3].

Personalized Medicine

The move toward personalized medicine is also influencing the rabeprazole sodium market. Tailored treatment approaches are becoming more common, reflecting a broader trend in healthcare toward more individualized care[3].

Market Projections

Revenue Forecasts

By 2032, the global rabeprazole sodium market is projected to reach over $984 million, driven by investments in healthcare infrastructure globally. This growth is supported by comprehensive quantitative and qualitative analyses of the current market outlook and future estimations[5].

Regional Outlook

Region-wise and country-wise conditions are being broadly evaluated to forecast future market potential. North America and Europe will continue to be significant markets, while the Asia Pacific region is expected to experience substantial growth due to the rising incidence of GERD and other digestive disorders[5].

Competitive Landscape

Major players in the market are profiled, and their key developmental strategies are being studied in detail. This provides insight into the competitive landscape of the global rabeprazole sodium industry. Analyses such as Porter’s five forces, SWOT analysis, COVID-19 impact, and PESTLE analysis are also being conducted to understand the market dynamics better[5].

Key Takeaways

• Clinical Efficacy: Rabeprazole sodium has shown high efficacy in treating GERD and other gastrointestinal disorders, including in pediatric patients.
• Market Growth: The global market is expected to grow significantly, driven by factors such as an aging population, changing dietary habits, and the availability of generic versions.
• Regional Dynamics: North America and Europe are current leaders, with the Asia Pacific region expected to see significant growth.
• Combination Therapies: There is a growing trend toward combination therapies to optimize treatment outcomes.
• Market Projections: The market is projected to reach over $984 million by 2032, driven by investments in healthcare infrastructure.

FAQs

What is rabeprazole sodium used for?

Rabeprazole sodium is used to treat gastroesophageal reflux disease (GERD), peptic ulcers, Zollinger-Ellison syndrome, and ulcers caused by Helicobacter pylori bacterial infections[5].

What is the mechanism of action of rabeprazole sodium?

Rabeprazole sodium works by inhibiting the gastric H+/K+ATPase at the secretory surface of the gastric parietal cell, reducing the amount of acid produced in the stomach[5].

What were the key findings of the FDA-approved clinical trial for pediatric use?

The clinical trial showed that 81% of pediatric patients achieved healing during the 12-week treatment period, and 90% retained healing during the subsequent 24-week extension period[1].

What are the common adverse events associated with rabeprazole sodium?

Common adverse events include cough, vomiting, abdominal pain, diarrhea, pyrexia, and headache[1].

What is the projected market size of rabeprazole sodium by 2032?

The global rabeprazole sodium market is expected to reach over $984 million by 2032[5].

Sources

1. FDA Approves ACIPHEX® Sprinkle™ (Rabeprazole Sodium) For Use in Children Ages 1 to 11. Eisai Inc., March 26, 2013.
2. Rabeprazole Sodium Market Size | Analysis Report - 2031. KBV Research.
3. Rabeprazole Sodium Market: Global Industry Analysis and Forecast. Maximize Market Research.
4. Efficacy and Safety After Multiple Doses of TNP-2198 Capsules (Rabeprazole Sodium Enteric-Coated Tablets and Amoxicillin Capsules). ClinicalTrials.gov.
5. Rabeprazole Sodium Market to Reach USD 984 million by 2032. Global Insight Services.