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.

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
Intragastric Acidity	1

Condition MeSH

Condition MeSH for Omeprazole; Sodium Bicarbonate
Intervention	Trials
Gastroesophageal Reflux	3
Heartburn	2
Esophagitis, Peptic	2
Hemorrhage	1

Clinical Trial Locations for Omeprazole; Sodium Bicarbonate

Trials by Country

Trials by Country for Omeprazole; Sodium Bicarbonate
Location	Trials
United States	31
Belgium	1
Egypt	1
Korea, Republic of	1
Poland	1

Trials by US State

Trials by US State for Omeprazole; Sodium Bicarbonate
Location	Trials
Missouri	3
Minnesota	2
Michigan	1
Massachusetts	1
Louisiana	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
Bausch Health Americas, Inc.	5
Valeant Pharmaceuticals International, Inc.	5
Bayer	4

Sponsor Type

Sponsor Type for Omeprazole; Sodium Bicarbonate
Sponsor	Trials
Industry	16
Other	7
U.S. Fed	1

Omeprazole + Sodium Bicarbonate: Clinical Trials Update, Market Analysis, and 2025-2035 Projection

Last updated: April 26, 2026

What is this drug and how is it positioned commercially?

Omeprazole plus sodium bicarbonate is a fixed-dose combination built around two mechanisms:

• Omeprazole (PPI): suppresses gastric acid by inhibiting the H+/K+ ATPase in parietal cells.
• Sodium bicarbonate (alkalinizer): provides immediate gastric pH elevation to support faster symptom control while omeprazole ramps up.

Commercial positioning depends on whether the product is:

• “Immediate” symptom relief + acid suppression (via bicarbonate buffering), or
• “Pure PPI” competition where clinical differentiation is judged on time-to-relief, breakthrough symptom rates, and patient satisfaction.

The market is dominated globally by generic PPIs, with differentiation largely driven by:

• formulary access (pricing and rebate),
• dosing convenience,
• time-to-relief claims,
• and managed care outcomes (work productivity and rescue medication use).

What does the clinical trial landscape look like?

Are there active or recent interventional trials?

This update cannot be completed to a standard suitable for investment or R&D decision-making because the underlying dataset needed for “clinical trials update” by trial status, phase, geography, endpoints, and sponsor is not present in the prompt. Without that dataset, any listing of “active trials” would be non-actionable.

What evidence exists conceptually for the combination class?

Across PPI + effervescent/alkalinizing combinations, the typical endpoints used by sponsors include:

• time to symptom relief (heartburn pain relief or “no/ mild” symptom status),
• acid exposure metrics (intragastric pH),
• rescue medication use through defined windows,
• and GERD symptom response durability (24 to 72 hours or longer in maintenance studies).

However, the prompt does not provide trial-level details (NCT numbers, phase, primary endpoints, results, or publication dates). A clinical update with hard data must cite those specifics.

What is the current market structure?

Where does demand come from?

Demand for omeprazole-driven therapy is anchored by:

• GERD prevalence and chronic reflux management,
• upper GI symptom management (dyspepsia cohorts),
• and guideline-based PPI use with step-up from H2 blockers.

Even where combinations add differentiation, PPI category economics still control pricing power because:

• patent protection for PPIs varies by molecule and territory,
• and generics compress unit pricing across most mature markets.

Competitive set

The realistic competitive set is:

• Generic PPIs (omeprazole and other PPIs),
• Other fixed combinations that use buffering or delayed-release approaches,
• OTC switch products in countries where reclassification enables self-medication.

Pricing and payer dynamics

In mature PPI categories, differentiation usually translates into:

• limited premium pricing versus generics,
• or premium access only in formulary segments where patients have unmet symptom control needs.

For bicarbonate-containing combinations, the commercial advantage tends to be:

• higher perceived speed of relief,
• potentially lower rescue medication use in early windows,
• and improved adherence due to symptom control experience.

Market analysis: 2025-2035 projection framework

A robust projection must incorporate:

• category size and CAGR,
• share shifts from branded to generic,
• share shifts among formulation types (delayed-release PPIs, effervescent/fast-acting variants),
• and geography-specific uptake (US, EU5, UK, Japan, LatAm, MENA, etc.).

The prompt provides no baseline market size, no current sales, and no territory scope. Any numeric forecast without those inputs would not meet the “hard data” requirement for a patent and product analytics use case.

Actionable business implications despite incomplete trial data

Even without trial-level listing, strategic conclusions can still be made from category structure:

1) Differentiation must show early symptom control

Because pricing power is structurally constrained by generic PPIs, the combination’s commercial thesis depends on patient-meaningful endpoints:

• time-to-relief,
• fewer breakthrough episodes,
• and reduced rescue use.

Any new development plan should prioritize proof on these endpoints in populations representative of payer and OTC/consumer behavior.

2) R&D should target payer-friendly endpoints

Managed care expects outcomes that map to utilization:

• rescue medication reduction,
• reduced outpatient visits related to reflux symptoms,
• and lower adherence discontinuation due to early symptom outcomes.

3) Safety and tolerability profile remains central

Sodium bicarbonate inclusion shifts attention to:

• sodium load considerations,
• GI tolerability,
• and suitability for patients with comorbidities where sodium restriction matters. Sponsors typically address this through controlled exposure assessment and tolerability monitoring.

Key Takeaways

• Omeprazole + sodium bicarbonate is a PPI-based regimen with an alkalinizing component intended to improve early symptom experience while omeprazole suppresses acid.
• The clinical trials update cannot be completed to an investment-grade standard because no trial-level dataset (NCT identifiers, phases, statuses, endpoints, results) is provided.
• Market outcomes for this combination are driven by the broader PPI category’s generic pricing compression, meaning commercial differentiation must demonstrate early symptom relief and payer-relevant outcomes.
• A 2025-2035 numeric projection requires baseline category sales, geography scope, and current share for the combination; without that, any figures would be non-actionable.

FAQs

1. Is omeprazole + sodium bicarbonate considered a distinct class versus standard omeprazole?
   It is a formulation-level differentiation within PPIs, with bicarbonate added to accelerate symptom control via buffering while omeprazole provides sustained acid suppression.

2. What endpoints typically matter most for this combination in GERD studies?
   Time to symptom relief, proportion of patients achieving “no/mild” heartburn at defined timepoints, rescue medication use, and intragastric pH response.

3. How do generics affect pricing power for this combination?
   Generic PPIs compress baseline pricing across the category, so the combination usually captures premium only where it demonstrates clinically meaningful early relief and better patient outcomes.

4. What safety issues are most relevant for sodium bicarbonate combinations?
   Sodium exposure considerations, GI tolerability, and patient suitability in populations where sodium restriction is relevant.

5. What drives formulary uptake for bicarbonate-containing PPI products?
   Evidence of early symptom control, adherence and rescue medication reduction, and alignment with managed care utilization goals, alongside competitive net pricing versus generic PPIs.

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References

[1] No sources were provided in the prompt.