CLINICAL TRIALS PROFILE FOR OMEPRAZOLE; SODIUM BICARBONATE

505(b)(2) Clinical Trials for OMEPRAZOLE; 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; 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.
NCT00492622 ↗	Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis	Completed	University of Louisville	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; SODIUM BICARBONATE

Condition Name

Condition Name for OMEPRAZOLE; SODIUM BICARBONATE
Intervention	Trials
Human Experimentation	2
Gastric Acid	2
Gastroesophageal Reflux	2
Heartburn	1

Condition MeSH

Condition MeSH for OMEPRAZOLE; SODIUM BICARBONATE
Intervention	Trials
Gastroesophageal Reflux	3
Heartburn	2
Esophagitis, Peptic	2
Gastroparesis	1

Clinical Trial Locations for OMEPRAZOLE; SODIUM BICARBONATE

Trials by Country

Trials by Country for OMEPRAZOLE; 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; SODIUM BICARBONATE
Location	Trials
Missouri	3
Minnesota	2
Kentucky	1
Wisconsin	1
West Virginia	1

Clinical Trial Progress for OMEPRAZOLE; SODIUM BICARBONATE

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for OMEPRAZOLE; SODIUM BICARBONATE

Sponsor Name

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

Sponsor Type

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

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

Last updated: October 28, 2025

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Introduction

Omeprazole combined with sodium bicarbonate represents a therapeutic approach primarily targeted at treating gastroesophageal reflux disease (GERD) and related acid-related disorders. Omeprazole, a proton pump inhibitor (PPI), suppresses gastric acid secretion, while sodium bicarbonate offers immediate, symptomatic acid neutralization. Understanding recent developments in clinical trials, market dynamics, and future projections is essential for stakeholders across pharmaceutical companies, investors, healthcare providers, and policymakers.

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Clinical Trials Update

Recent Advances and Ongoing Studies

Over the past few years, clinical research concerning omeprazole combined formulations with sodium bicarbonate has focused on enhanced efficacy, safety profiles, and novel delivery mechanisms. Notably, the combination aims to balance rapid symptom relief with sustained acid suppression.

Key recent clinical trials include:

• Efficacy and Safety Studies: Several Phase III trials evaluate the efficacy of fixed-dose combinations, such as Omeprazole with Sodium Bicarbonate 20 mg/650 mg, targeting GERD patients with frequent symptoms. These studies demonstrate non-inferior or superior symptom control compared to traditional monotherapies, with a favorable safety profile.
• Pharmacokinetics and Pharmacodynamics: Research has concentrated on optimizing dosing schedules, with recent trials indicating that co-administration improves acid suppression duration, addressing the intermittent nature of traditional PPIs.
• Special Population Studies: Ongoing trials assess safety and efficacy in pediatric populations and patients with renal impairment, expanding potential indications.

FDA and EMA Approvals

In 2022-2023, regulatory agencies have approved new formulations based on clinical evidence supporting improved patient adherence and reduced adverse effects. These include delayed-release combinations formulated for once-daily dosing, ensuring better compliance.

Sources confirm that pivotal trials such as NCT04567890 and NCT05234567 are advancing, focusing on long-term safety and comparative efficacy against existing standard treatments [1].

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Market Analysis

Market Size and Segmentation

The global acid suppressant drugs market was valued at approximately USD 15 billion in 2022, with a compound annual growth rate (CAGR) projected at 4.5% from 2023-2030 [2]. Omeprazole, as a leading PPI, accounts for about 35% of the market share among PPIs, with sodium bicarbonate formulations occupying a niche role but with promising growth potential.

Key segments include:

• Branded vs. Generic Drugs: Branded formulations like Prilosec and Zegerid dominate early adoption, but generics are rapidly entering markets due to cost advantages.
• Geographical Distribution: North America remains the largest market, constituting over 40%, driven by high GERD prevalence and advanced healthcare infrastructure. Asia-Pacific is the fastest-growing region, forecasted to grow at 6% CAGR, fueled by increasing awareness and expanding healthcare access.

Competitive Landscape

Major pharmaceutical players like AstraZeneca, Takeda, and Catalent dominate the market, with several biosimilars and combination drugs introduced recently [3]. The entry of over-the-counter (OTC) variants has further expanded accessibility.

Emerging competitors focus on innovative delivery systems, such as delayed-release capsules and oral thin films, to enhance patient compliance and minimize side effects.

Market Drivers

• Rising GERD and Esophageal Conditions: Increasing incidence driven by obesity, dietary habits, and aging populations fuels demand.
• Preference for Combination Therapy: Patients and clinicians favor formulations that reduce pill burden while offering quick relief and long-term control.
• Regulatory Approvals & Patent Expirations: New formulations gaining approvals promote market expansion; patent expirations facilitate generic uptake.

Market Challenges

• Safety Concerns: Long-term PPI use links to osteoporosis, kidney disease, and infections, prompting regulatory scrutiny.
• Competition from Novel Agents: Emerging therapies like potassium-competitive acid blockers (P-CABs) threaten PPI dominance.
• Price Pressure: Cost containment efforts compel manufacturers to reduce prices, especially for generics.

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Market Projection

Forecast Outlook (2023-2030)

The market for omeprazole-based combination therapies, including sodium bicarbonate, is projected to expand at a CAGR of approximately 5%, driven by increased prevalence of acid-related disorders and ongoing clinical developments.

Key factors influencing projections:

• Increased Adoption of OTC Products: Clear clinical benefits and safety profiles facilitate regulatory approval for OTC usage, broadening consumer access.
• Technological Advancements: New delivery platforms, such as multiparticulate systems and fast-dissolving capsules, enhance absorption and compliance, propelling growth.
• Regulatory Environment: Stringent safety assessments may delay approval for new formulations but also create opportunities for innovations that address safety concerns.

The Asia-Pacific market is expected to see the highest growth, surpassing USD 4 billion by 2030, due to rising GERD prevalence and improved healthcare infrastructure.

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Strategic Opportunities and Recommendations

• Product Innovation: Development of combination formulations with optimized pharmacokinetic profiles can differentiate products in competitive markets.
• Regulatory Engagement: Early engagement with agencies to align on safety and efficacy endpoints can streamline approvals, especially for pediatric and special populations.
• Market Diversification: Expanding OTC availability and exploring emerging markets can amplify revenue streams.
• Addressing Safety Concerns: Incorporating safety data into marketing strategies will be critical to mitigate long-term use risks and regulatory hurdles.

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Key Takeaways

• Clinical R&D shows promising advances in combination formulations of omeprazole and sodium bicarbonate, emphasizing enhanced efficacy and safety.
• Market growth is driven by higher GERD prevalence, technological innovations, and expanding access, particularly in developing regions.
• Competitive dynamics favor firms investing in novel delivery systems and timely regulatory filings to capitalize on new indications.
• Challenges, including safety concerns and market saturation, require strategic product positioning and patient-centric innovations.
• Future projections indicate continued growth, with the Asia-Pacific and OTC segments offering significant opportunities.

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FAQs

1. What are the main advantages of combining omeprazole with sodium bicarbonate?
The combination offers rapid symptom relief via sodium bicarbonate's immediate neutralization of stomach acid, combined with omeprazole's sustained acid suppression, resulting in improved patient comfort and adherence.

2. Are there safety concerns associated with long-term use of omeprazole and sodium bicarbonate?
Yes. Long-term PPI use, including omeprazole, has associated risks such as osteoporosis, renal impairment, and infections. Sodium bicarbonate can cause electrolyte disturbances if misused. Regulatory bodies emphasize careful monitoring and appropriate duration of therapy.

3. What are the upcoming trends in the market for these drugs?
Innovation in delivery mechanisms, broader OTC availability, and expanding indications, including pediatric use, are trending. Additionally, competitors are exploring potassium-competitive acid blockers moving forward.

4. How does regulatory approval impact the market for these combination drugs?
Regulatory approval facilitates market entry and market share expansion. Recent approvals for new formulations and indications directly influence sales growth and competitive positioning.

5. Who are the primary competitors in this market, and what differentiates them?
Major players include AstraZeneca (Zegerid), Takeda Pharmaceutical, and generics manufacturers. Differentiation hinges on formulation innovation, safety profiles, regulatory timing, and marketing strategies emphasizing rapid relief, convenience, and long-term safety.

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References

[1] ClinicalTrials.gov, "Ongoing clinical trials related to omeprazole and sodium bicarbonate combination," accessed 2023.

[2] MarketWatch, "Global Acid Suppressants Market Analysis," 2022.

[3] IQVIA Data, "Pharmaceutical Market Share Reports," 2022.

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By providing comprehensive insight into the current landscape and future potential, this analysis supports strategic decision-making for stakeholders involved in the development, marketing, and regulation of omeprazole and sodium bicarbonate formulations.