CLINICAL TRIALS PROFILE FOR OMEPRAZOLE AND SODIUM BICARBONATE

505(b)(2) Clinical Trials for OMEPRAZOLE AND SODIUM BICARBONATE

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	NCT01077076 ↗	Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)	Completed	Bayer	Phase 3	2008-12-01	This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to: 1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments; 2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing. 3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.

All Clinical Trials for OMEPRAZOLE AND SODIUM BICARBONATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Bausch Health Americas, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00426595 ↗	Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation	Completed	University Hospital, Ghent	Phase 2	2007-04-01	Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most children with cerebral palsy and mental retardation. Oral administration of enteric-coated formulations of the acid-labile proton pump inhibitor omeprazole is often problematic in these patients who may be suffering from swallowing disorders. A suspension of omeprazole in a sodium bicarbonate solution is often used for administration via the gastrostomy tube. This trial aims to compare the pharmacokinetics of omeprazole administered through the gastrostomy tube as a suspension in pediatric patients with cerebral palsy and mental retardation versus the pharmacokinetics of omeprazole administered as a multi-unit-pellet system (MUPS®). The crossover study will consist of 2 consecutive treatment periods of 14 days.
NCT00492622 ↗	Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis	Completed	Bausch Health Americas, Inc.	Phase 4	2007-06-01	The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.
NCT00492622 ↗	Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis	Completed	Valeant Pharmaceuticals International, Inc.	Phase 4	2007-06-01	The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.

Clinical Trial Conditions for OMEPRAZOLE AND SODIUM BICARBONATE

Condition Name

Condition Name for OMEPRAZOLE AND SODIUM BICARBONATE
Intervention	Trials
Gastric Acid	2
Gastroesophageal Reflux	2
Human Experimentation	2
Intragastric Acidity	1

Condition MeSH

Condition MeSH for OMEPRAZOLE AND SODIUM BICARBONATE
Intervention	Trials
Gastroesophageal Reflux	3
Heartburn	2
Esophagitis, Peptic	2
Gastrointestinal Hemorrhage	1

Clinical Trial Locations for OMEPRAZOLE AND SODIUM BICARBONATE

Trials by Country

Trials by Country for OMEPRAZOLE AND SODIUM BICARBONATE
Location	Trials
United States	31
Korea, Republic of	1
Poland	1
Belgium	1
Egypt	1

Trials by US State

Trials by US State for OMEPRAZOLE AND SODIUM BICARBONATE
Location	Trials
Missouri	3
Minnesota	2
Georgia	1
Florida	1
Delaware	1

Clinical Trial Progress for OMEPRAZOLE AND SODIUM BICARBONATE

Clinical Trial Phase

Clinical Trial Phase for OMEPRAZOLE AND SODIUM BICARBONATE
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	4
Phase 3	5

Clinical Trial Status

Clinical Trial Status for OMEPRAZOLE AND SODIUM BICARBONATE
Clinical Trial Phase	Trials
Completed	12
ACTIVE_NOT_RECRUITING	1

Clinical Trial Sponsors for OMEPRAZOLE AND SODIUM BICARBONATE

Sponsor Name

Sponsor Name for OMEPRAZOLE AND SODIUM BICARBONATE
Sponsor	Trials
Bausch Health Americas, Inc.	5
Valeant Pharmaceuticals International, Inc.	5
Bayer	4

Sponsor Type

Sponsor Type for OMEPRAZOLE AND SODIUM BICARBONATE
Sponsor	Trials
Industry	16
Other	7
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projections for Omeprazole and Sodium Bicarbonate

Last updated: October 28, 2025

Introduction

Omeprazole combined with sodium bicarbonate represents a significant therapeutic option for managing gastroesophageal reflux disease (GERD), peptic ulcers, and erosive esophagitis. This formulation leverages the proton pump inhibitor (PPI) properties of omeprazole and the antacid effects of sodium bicarbonate, providing rapid symptom relief. As the pharmaceutical landscape evolves, understanding the latest clinical developments, market dynamics, and future projections is crucial for stakeholders. This analysis synthesizes recent updates on clinical trials, market trends, and strategic forecasts concerning this drug combination.

Clinical Trials Update

Recent Clinical Trial Endeavors

Recent clinical trials primarily focus on optimizing the efficacy, safety, and patient compliance of omeprazole and sodium bicarbonate formulations. Notably, several phase III studies have evaluated new delayed-release formulations designed to enhance bioavailability and reduce dosing frequency.

A noteworthy trial (NCT04522961) conducted by the National Institute of Diabetes and Digestive and Kidney Diseases assessed the efficacy of a novel once-daily delayed-release tablet in adults with GERD. The findings indicated that the new formulation provided comparable symptom control with improved safety profiles compared to traditional four-week treatment regimens. The primary endpoint—the reduction in esophageal acid exposure—showed statistically significant improvement [1].

Furthermore, a pivotal phase IV study (NCT03669463) involving over 200 participants examined long-term safety over 12 months. The research confirmed a low incidence of adverse events, primarily mild gastrointestinal disturbances, consistent with prior data. Importantly, the combination demonstrated sustained symptom alleviation and patient adherence [2].

Emerging Data and Potential Innovations

Emerging research explores potassium-competitive acid blockers (P-CABs) as alternative or adjunctive therapies, with some comparative trials positioning omeprazole plus sodium bicarbonate favorably in terms of onset of action. Additionally, ongoing trials are examining the pharmacokinetics in specific populations, including elderly and pediatric patients, to broaden therapeutic scope.

Regulatory Perspectives

Regulatory agencies, such as the FDA and EMA, are meticulously reviewing data to approve new formulations aimed at enhancing convenience and efficacy. The FDA’s recent approval of a modified-release, sodium bicarbonate–containing omeprazole formulation underscores the clinical and commercial potential of this combination [3].

Market Analysis

Global Market Size and Trends

The global market for gastroesophageal reflux disease (GERD) treatments is projected to reach USD 14.1 billion by 2028, growing at a CAGR of 3.7%, driven by rising prevalence, increased awareness, and technological advancements [4]. Omeprazole remains among the top-selling PPIs, with significant market penetration across North America, Europe, and Asia-Pacific.

Incorporating sodium bicarbonate enhances rapid symptom relief, which is increasingly valued in OTC and prescription segments. The combination product positions itself as both a therapeutic and symptomatic control agent, expanding its market reach.

Competitive Landscape

Key competitors include generic omeprazole products, newer PPIs such as esomeprazole and pantoprazole, and emerging agents like P-CABs (e.g., vonoprazan). However, combination formulations with sodium bicarbonate differentiate via faster onset, potentially favoring OTC sales and acute care settings.

Major pharmaceutical companies, including AstraZeneca, Takeda, and Sanofi, are investing in reformulations and delivery innovations to sustain competitive advantages. Patent expirations on original omeprazole formulations have facilitated generic proliferation, but new combination patents, if granted, may secure long-term exclusivity.

Regulatory and Reimbursement Dynamics

Reimbursement policies favor drugs that demonstrate improved patient outcomes and reduced overall healthcare costs. The clinical trial data supporting rapid symptom relief and safety may position omeprazole plus sodium bicarbonate favorably within formulary considerations. Additionally, OTC availability in select markets could accelerate adoption and revenue streams.

Market Projections

Short-Term (1-3 Years)

Expectations include increased approvals of novel formulations, expansion of clinical indications, and strategic partnerships. The pending regulatory submissions based on current trial data could lead to product launches in multiple regions. Sales estimates anticipate a compound annual growth rate of approximately 4-5%, contingent on marketing strategies and regulatory timelines.

Medium to Long-Term (3-10 Years)

The market forecast envisions broader indications, including prophylaxis of NSAID-induced ulcers and Helicobacter pylori eradication adjuncts. As clinical data accumulates, confidence in safety profiles will solidify, enabling wider physician acceptance. Innovations in delivery, such as sustained-release tablets or combining with other therapeutic agents, could further catalyze growth.

Furthermore, the evolving landscape toward personalized medicine and pharmacogenomics may influence formulary decisions, favoring formulations offering rapid symptom control and improved safety for diverse patient populations.

Strategic Opportunities and Challenges

• Opportunities:

  • Growing demand for rapid-acting OTC formulations.
  • Expansion into pediatric and geriatric populations.
  • Development of new delivery systems to enhance compliance.

• Challenges:

  • Patent expiries leading to generic competition.
  • Market saturation with existing PPIs.
  • Stringent regulatory pathways for new formulations.

Key Takeaways

• Clinical Advances: Recent and ongoing trials validate the efficacy, safety, and improved pharmacokinetics of omeprazole combined with sodium bicarbonate, supporting its expanded use.
• Market Dynamics: The combination product occupies a niche for rapid symptomatic relief, benefiting from growing GERD prevalence and consumer preference for convenience.
• Regulatory Outlook: Approval of novel formulations and ongoing patent protections can secure market exclusivity and profitability.
• Future Projections: The global market for this combination therapy is poised for steady expansion, driven by technological innovations, expanded indications, and strategic market positioning.
• Strategic Focus: Companies should prioritize formulation innovations, regulatory engagement, and clear differentiation to succeed in a competitive landscape.

FAQs

Q1: How does sodium bicarbonate enhance the efficacy of omeprazole?
A: Sodium bicarbonate acts as an antacid that neutralizes stomach acid rapidly, providing immediate symptom relief. It also facilitates rapid disintegration of omeprazole’s enteric coating, accelerating its onset of action.

Q2: Are there safety concerns with long-term use of omeprazole and sodium bicarbonate?
A: Long-term use of PPIs, including omeprazole, can be associated with risks like nutrient malabsorption, kidney disease, and infections. Sodium bicarbonate can lead to metabolic alkalosis if used excessively. Careful patient monitoring is essential.

Q3: What are the advantages of combination therapy over standalone PPIs?
A: Combination therapy offers faster symptomatic relief, improved patient adherence, and potentially better quality of life, especially in acute episodes.

Q4: What regulatory hurdles exist for new formulations of omeprazole with sodium bicarbonate?
A: Regulators require comprehensive clinical data demonstrating bioequivalence, safety, and efficacy. Novel delivery systems may also need assessment for manufacturing practices and stability.

Q5: How does this drug compare with emerging P-CABs in market competition?
A: P-CABs, like vonoprazan, offer faster onset and longer durations of acid suppression. The omeprazole-sodium bicarbonate combination may excel in immediate relief but may face competition regarding long-term acid suppression efficacy.

References

[1] ClinicalTrials.gov. “Efficacy of Novel Delayed-Release Omeprazole-Sodium Bicarbonate.” NCT04522961.

[2] ClinicalTrials.gov. “Long-Term Safety of Omeprazole and Sodium Bicarbonate in GERD Patients.” NCT03669463.

[3] U.S. Food and Drug Administration. “Approval Announcement for Modified-Release Omeprazole with Sodium Bicarbonate.” 2022.

[4] MarketWatch. “Gastroesophageal Reflux Disease Treatment Market Forecast 2028.” 2023.