CLINICAL TRIALS PROFILE FOR ZEGERID

505(b)(2) Clinical Trials for Zegerid

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 Zegerid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00557349 ↗	Ulcer Prevention Study in Post Gastric Bypass Patients	Completed	University of Missouri-Columbia	Phase 4	2006-11-01	This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer after gastric bypass surgery.
NCT00674115 ↗	A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)	Completed	Bausch Health Americas, Inc.	Phase 3	2008-04-01	Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.
NCT00674115 ↗	A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2008-04-01	Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.
NCT00674115 ↗	A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)	Completed	Bayer	Phase 3	2008-04-01	Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.
NCT00693225 ↗	Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study	Completed	Bausch Health Americas, Inc.	Phase 4	2008-01-01	The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
NCT00693225 ↗	Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study	Completed	Valeant Pharmaceuticals International, Inc.	Phase 4	2008-01-01	The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
NCT00693225 ↗	Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study	Completed	Yvonne Romero	Phase 4	2008-01-01	The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.

Clinical Trial Conditions for Zegerid

Condition Name

Condition Name for Zegerid
Intervention	Trials
Human Experimentation	3
Gastroesophageal Reflux	2
Gastric Acid	2
Healthy Volunteers	1

Condition MeSH

Condition MeSH for Zegerid
Intervention	Trials
Gastroesophageal Reflux	3
Esophagitis, Peptic	2
Heartburn	2
Barrett Esophagus	1

Clinical Trial Locations for Zegerid

Trials by Country

Trials by Country for Zegerid
Location	Trials
United States	14
India	5
Canada	4
Argentina	3
United Kingdom	3

Trials by US State

Trials by US State for Zegerid
Location	Trials
Nebraska	1
Arizona	1
Texas	1
Pennsylvania	1
Oregon	1

Clinical Trial Progress for Zegerid

Clinical Trial Phase

Clinical Trial Phase for Zegerid
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	6
Phase 1	3

Clinical Trial Status

Clinical Trial Status for Zegerid
Clinical Trial Phase	Trials
Completed	12
Terminated	1

Clinical Trial Sponsors for Zegerid

Sponsor Name

Sponsor Name for Zegerid
Sponsor	Trials
Bayer	5
Bausch Health Americas, Inc.	3
Valeant Pharmaceuticals International, Inc.	3

Sponsor Type

Sponsor Type for Zegerid
Sponsor	Trials
Industry	15
Other	4

ZEGERID: Clinical Trials, Market Analysis, and Projections

Introduction

ZEGERID, a proton pump inhibitor (PPI) combining omeprazole and sodium bicarbonate, has been a significant player in the treatment of gastroesophageal reflux disease (GERD) and other acid-related disorders. This article will delve into the clinical trials, market analysis, and future projections for ZEGERID.

Clinical Trials Overview

Phase III Study: Zegerid vs. Losec

A Phase III, multicenter, double-blind, double-dummy, randomized study compared the efficacy of ZEGERID (omeprazole 20 mg and sodium bicarbonate) with Losec (standard enteric-coated omeprazole) for rapid relief of heartburn associated with GERD. The study found that while ZEGERID did not demonstrate superiority over Losec in terms of median time to sustained response, both treatments were equally effective. However, ZEGERID showed a faster onset of action, with more patients achieving sustained total relief within 0-30 minutes post-dose[1].

Bioavailability and Pharmacokinetics

Studies have also compared the bioavailability of ZEGERID with other PPIs, such as Prilosec. A clinical pharmacology review indicated that ZEGERID powder for oral suspension had lower bioavailability parameters (Cmax and AUCinf) compared to Prilosec 40 mg capsules. This suggests that while ZEGERID may offer rapid relief, its bioavailability might be lower in some formulations[3].

Efficacy in Critically Ill Patients

ZEGERID has also been studied in critically ill patients for the reduction of risk of upper gastrointestinal (GI) bleeding. A study comparing ZEGERID with continuous IV cimetidine showed that ZEGERID was non-inferior to cimetidine in preventing clinically significant upper GI bleeding[4].

Market Analysis

Unique Selling Proposition

ZEGERID's patented dual-ingredient formula, combining omeprazole with sodium bicarbonate, sets it apart from other OTC PPIs. This formulation allows omeprazole to be absorbed quickly without the need for an enteric coating, providing rapid relief from heartburn and other GERD symptoms[2].

Market Presence

ZEGERID is available in various forms, including capsules and oral suspension, and is indicated for a range of conditions including active duodenal ulcer, benign gastric ulcer, erosive esophagitis, and symptomatic GERD. Its availability over-the-counter (OTC) has expanded its market reach, making it accessible to a broader consumer base[5].

Competitive Landscape

The PPI market is highly competitive, with brands like Prilosec, Nexium, and Prevacid. However, ZEGERID's unique formulation and rapid onset of action give it a competitive edge. The OTC market, in particular, has seen significant growth, with ZEGERID positioning itself as a leading brand in this segment[2].

Market Projections

Growing Demand for PPIs

The demand for PPIs is expected to continue growing due to increasing prevalence of GERD and other acid-related disorders. Lifestyle factors, such as diet and obesity, are contributing to this trend, making PPIs a staple in many households.

Expanding Indications

ZEGERID's indications are likely to expand beyond current uses, particularly in the management of critically ill patients and in the prevention of upper GI bleeding. This could further solidify its position in the market.

Consumer Preferences

Consumers are increasingly seeking rapid and effective relief from heartburn and GERD symptoms. ZEGERID's ability to provide quick relief, coupled with its ease of use and availability OTC, positions it well to meet these consumer demands.

Safety and Side Effects

General Safety Profile

ZEGERID has been shown to be well-tolerated in clinical trials, with no significant safety concerns raised. However, like all PPIs, it carries risks such as ECL cell hyperplasia and the potential for systemic alkalosis due to the sodium bicarbonate content[4][5].

Sodium Content Considerations

The sodium content in ZEGERID products is a consideration for patients on sodium-restricted diets or those at risk for congestive heart failure. This aspect needs to be carefully managed to ensure safe use[5].

Key Takeaways

• Clinical Efficacy: ZEGERID is equally effective as other PPIs like Losec for heartburn relief and offers a faster onset of action.
• Market Position: Its unique dual-ingredient formulation and OTC availability make it a competitive player in the PPI market.
• Future Projections: Growing demand for PPIs, expanding indications, and consumer preferences for rapid relief are expected to drive ZEGERID's market presence.
• Safety Considerations: While generally well-tolerated, the sodium content and potential for systemic alkalosis need careful management.

FAQs

Q: What is the unique feature of ZEGERID compared to other PPIs?

A: ZEGERID's unique feature is its patented dual-ingredient formula combining omeprazole with sodium bicarbonate, which allows for rapid absorption without an enteric coating.

Q: Is ZEGERID available over-the-counter?

A: Yes, ZEGERID is available OTC in various forms, including capsules and oral suspension.

Q: What are the common indications for ZEGERID?

A: ZEGERID is indicated for the treatment of active duodenal ulcer, benign gastric ulcer, erosive esophagitis, and symptomatic GERD.

Q: How does ZEGERID compare to Losec in terms of efficacy?

A: ZEGERID and Losec are equally effective for heartburn relief, but ZEGERID has a faster onset of action.

Q: What are the potential side effects of ZEGERID due to its sodium bicarbonate content?

A: The sodium bicarbonate in ZEGERID can lead to systemic alkalosis and is a consideration for patients on sodium-restricted diets or those at risk for congestive heart failure.

Sources

1. PubMed: A phase III, randomized study of Zegerid versus Losec - PubMed
2. BioSpace: Merck & Co., Inc.'s ZEGERID OTC(TM) Hits Store Shelves - BioSpace
3. FDA: 022283Orig1s000 - accessdata.fda.gov
4. FDA: ZEGERID® - accessdata.fda.gov
5. Drugs.com: Zegerid: Package Insert / Prescribing Information - Drugs.com