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.

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

Condition MeSH

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

Clinical Trial Locations for Omeprazole; Sodium Bicarbonate

Trials by Country

Trials by Country for Omeprazole; Sodium Bicarbonate
Location	Trials
United States	31
Belgium	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
Phase 4	4
Phase 3	5
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Omeprazole; Sodium Bicarbonate
Clinical Trial Phase	Trials
Completed	12

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	6
U.S. Fed	1

Omeprazole and Sodium Bicarbonate: Clinical Trials, Market Analysis, and Projections

Introduction

Omeprazole, a proton pump inhibitor (PPI), combined with sodium bicarbonate, has been a significant focus in the treatment of various gastrointestinal disorders, including gastric ulcers, duodenal ulcers, and gastroesophageal reflux disease (GERD). This article will delve into the clinical trials, market analysis, and projections for this drug combination.

Clinical Trials and Efficacy

Gastric and Duodenal Ulcers

A multicenter, randomized, double-blind, double-dummy clinical trial evaluated the efficacy and safety of omeprazole and sodium bicarbonate suspension in treating gastric ulcers (GU) and duodenal ulcers (DU). The study found that after 8 weeks of treatment, the total effective rates of clinical symptom relief for GU were 95.76% in the experimental group compared to the control group[1].

Gastroesophageal Reflux Disease (GERD)

Studies comparing omeprazole/sodium bicarbonate with omeprazole alone in treating GERD showed that while both therapies were effective in reducing acidity, the combination had a tendency towards a more sustained response and faster relief. For instance, one study indicated that omeprazole/sodium bicarbonate achieved a sustained response in 81.1% of patients, compared to 75.2% with omeprazole alone[4].

Mechanism of Action

The addition of sodium bicarbonate to omeprazole facilitates faster dissolution and absorption, leading to a higher peak concentration (Cmax) and shorter time to reach peak concentration (Tmax) compared to delayed-release capsules. This formulation protects the uncoated omeprazole from acid degradation, resulting in a faster start to the suppression of gastric acidity[4][5].

Market Analysis

Market Size and Growth

The omeprazole and antihistamine market is projected to register a Compound Annual Growth Rate (CAGR) of 5.70% during the forecast period from 2024 to 2029. This growth is driven by the increasing prevalence of GERD, the demand for over-the-counter (OTC) medications, and the rising awareness of the benefits of PPIs[2].

Regional Market Dynamics

North America is expected to hold the largest market share due to the high prevalence of gastrointestinal disorders such as gastric ulcers and GERD. The Asia Pacific region is anticipated to be the fastest-growing market during the forecast period[2].

Key Players

Major companies operating in the omeprazole and antihistamine market include Bayer AG, Novartis, Pfizer, Procter & Gamble, and Teva Pharmaceutical. These companies are driving market growth through product launches and approvals[2].

FDA Approvals and Commercial Availability

Konvomep Approval

In September 2022, the FDA approved Azurity Pharmaceuticals' Konvomep, an oral liquid formulation of omeprazole and sodium bicarbonate, for the treatment of active benign gastric ulcers and to reduce the risk of upper gastrointestinal bleeding in critically ill patients. This approval addresses the need for liquid formulations, particularly for patients who struggle with solid oral dosage forms[3].

Market Drivers

Increasing Prevalence of Gastrointestinal Disorders

The growing prevalence of GERD and other gastrointestinal conditions is a significant driver of the market. For example, GERD affects 20% of adults in Western societies, and regurgitation or vomiting in infants can increase the demand for omeprazole-based treatments[2].

Product Approvals and Innovations

Recent approvals, such as the FDA approval of Konvomep, are driving market growth. These innovations provide patients with more treatment options, especially those who have difficulty swallowing pills or capsules[3].

Challenges and Considerations

Safety Concerns

While the combination of omeprazole and sodium bicarbonate is generally safe, there are safety concerns, particularly in children aged 0-2 years, where dosing with sodium bicarbonate is undesirable due to potential safety risks[5].

Study Limitations

Clinical trials have shown some limitations, including the heterogeneity of studies and the potential for type II errors, which can make direct comparisons between omeprazole/sodium bicarbonate and omeprazole alone challenging[4].

Conclusion

The combination of omeprazole and sodium bicarbonate has demonstrated efficacy in treating various gastrointestinal disorders. Clinical trials have shown promising results, especially in terms of faster absorption and sustained relief. The market for this drug combination is expected to grow significantly, driven by increasing prevalence of gastrointestinal conditions and recent FDA approvals.

Key Takeaways

• Efficacy: Omeprazole and sodium bicarbonate combination shows high efficacy in treating gastric ulcers, duodenal ulcers, and GERD.
• Market Growth: The market is projected to grow at a CAGR of 5.70% from 2024 to 2029.
• Regional Dynamics: North America holds the largest market share, while the Asia Pacific region is the fastest-growing.
• FDA Approvals: Recent approvals, such as Konvomep, are driving market growth and providing more treatment options.
• Safety Considerations: Safety concerns exist, particularly in young children.

FAQs

What is the primary use of omeprazole and sodium bicarbonate?

Omeprazole and sodium bicarbonate are primarily used to treat gastrointestinal disorders such as gastric ulcers, duodenal ulcers, and gastroesophageal reflux disease (GERD).

Which region is expected to grow the fastest in the omeprazole and antihistamine market?

The Asia Pacific region is expected to be the fastest-growing market during the forecast period from 2024 to 2029[2].

What is the significance of the FDA approval of Konvomep?

The FDA approval of Konvomep provides a liquid formulation option for patients, particularly those who struggle with solid oral dosage forms, and addresses the need for more treatment options for benign gastric ulcers and upper gastrointestinal bleeding[3].

How does the addition of sodium bicarbonate affect omeprazole?

The addition of sodium bicarbonate facilitates faster dissolution and absorption of omeprazole, leading to a higher peak concentration and shorter time to reach peak concentration compared to delayed-release capsules[4][5].

What are the safety concerns associated with omeprazole and sodium bicarbonate in children?

Dosing with sodium bicarbonate in children aged 0-2 years is undesirable due to potential safety concerns, as highlighted in FDA discussions and studies[5].

References

1. Martins Neto, V. Efficacy of omeprazole and sodium bicarbonate suspension in the treatment of peptic ulcer. BVS.
2. Mordor Intelligence. Omeprazole And Antihistamine Market Size & Share Analysis.
3. Pharmacy Times. FDA Approves Oral Liquid Formulation to Treat Gastric Issues.
4. Medwave. Efficacy of omeprazole/sodium bicarbonate treatment in gastroesophageal reflux disease.
5. FDA. OFFICE OF CLINICAL PHARMACOLOGY REVIEW NDA.

Last updated: 2024-12-31