CLINICAL TRIALS PROFILE FOR PREVACID 24 HR

All Clinical Trials for PREVACID 24 HR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00211614 ↗	Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea	Withdrawn	MetroHealth Medical Center	N/A	2006-07-01	Obstructive Sleep Apnea (OSA) is common in modern society, affecting up to 5% of working middle-aged adults in the United States. Obesity is the number one risk factor for the development of OSA. Consequences of untreated OSA are varied and significant and included numerous neuropsychiatric parameters such as mood alterations, depression, anxiety, diminished social interactions, and decreased quality of life. Mounting evidence suggests that treatment of OSA can improve many of these outcomes. The primary treatment modality for this condition is continuous positive airway pressure (CPAP). This device delivers positive pressure to the upper airway in order to prevent its collapse during sleep. Unfortunately, many patients do not choose to use CPAP or have difficulty with these devices. This results in many individuals with OSA either going without therapy or unable to reap the full benefits of treatment. Gastroesophageal reflux (GERD) is also common in the United States and may, in some instances, be directly related to weight gain. Survey studies have suggested that symptomatic GERD is more common in patients with OSA. Whether there exists a cause and effect relationship between these two conditions is not known at present. It has been suggested that GERD may contribute to OSA by narrowing the upper airway. This study will examine the effect of treatment of GERD on mild to moderate OSA. Fifty individuals identified as having mild to moderate OSA (diagnosed by overnight sleep study or PSG) and GERD (confirmed by an esophageal probe) will be enrolled. Both men and women will be included in this study and no "special populations" will be utilized. Subjects will fill out questionnaires to subjectively measure sleepiness, OSA-related symptoms, GERD-related symptoms, and sleep apnea-related quality of life. They will then be randomized to receive either 12 weeks of the proton pump inhibitor lansoprazole (Prevacid) or placebo (twenty five subjects per group). Upon completion of the 12 week trial, subjects will return and the following data will be collected; repeat all of the baseline questionnaires, repeat PSG and repeat pH probe. Results from this study will help to establish the relative effectiveness of a novel form of therapy for a common yet difficult to manage medical condition. . The risks to subjects enrolled in the study are minimal and therefore the benefit to risk ratio is heavily in favor of performing the study.
NCT00239551 ↗	Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer	Completed	TAP Pharmaceutical Products Inc.	Phase 4	2005-10-01	The purpose of this study is to measure the prostaglandin levels in patients with stress ulcer and the effect of Prevacid on prostaglandin levels in patients with stress ulcer.
NCT00239551 ↗	Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer	Completed	Emory University	Phase 4	2005-10-01	The purpose of this study is to measure the prostaglandin levels in patients with stress ulcer and the effect of Prevacid on prostaglandin levels in patients with stress ulcer.
NCT00215787 ↗	Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease	Completed	Head and Neck Surgery Associates	N/A	2005-09-01	Although nasal polyposis has been recognized as an inflammatory process for many years, the true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence rate after surgery has been reported as high as 87% within the first year after surgery. Anecdotally the Principal Investigator found an incidence of pH probe-proven laryngopharyngeal reflux approaching 80% in his patients with nasal polyposis. Although his number of cases was small, the incidence of recurrence of polyps in these patients was 17%. The PI believes that such an association is too great to be explained by chance alone, and deserves further study. He anticipates two contributions to the literature from this study, the first documenting the incidence of extraesophageal (laryngopharyngeal) reflux in patients with polyposis, and the second showing the impact of reflux treatment on the recurrence rate of the polyps, initially after one year of therapy.
NCT00230516 ↗	Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects	Completed	AstraZeneca	Phase 4	2005-09-01	This study is intended to evaluate whether intravenous (iv) esomeprazole (Nexium® ) offers better intragastric acid suppression than iv lansoprazole (Prevacid ®
NCT00204373 ↗	Treatment of Zollinger-Ellison Syndrome With Prevacid	Completed	Takeda Pharmaceuticals North America, Inc.	Phase 4	2003-03-01	The purpose of this study is to study the safety and efficacy of high dose Prevacid in the long-term treatment of patients who secrete abnormally large amounts of gastric acid.
NCT00204373 ↗	Treatment of Zollinger-Ellison Syndrome With Prevacid	Completed	Charles Mel Wilcox, MD	Phase 4	2003-03-01	The purpose of this study is to study the safety and efficacy of high dose Prevacid in the long-term treatment of patients who secrete abnormally large amounts of gastric acid.

Clinical Trial Conditions for PREVACID 24 HR

Condition Name

Condition Name for PREVACID 24 HR
Intervention	Trials
Healthy	9
Gastroesophageal Reflux	6
Erosive Esophagitis	4
Asthma	3

Condition MeSH

Condition MeSH for PREVACID 24 HR
Intervention	Trials
Gastroesophageal Reflux	14
Esophagitis	6
Laryngopharyngeal Reflux	3
Ulcer	3

Clinical Trial Locations for PREVACID 24 HR

Trials by Country

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Trials by Country for PREVACID 24 HR
Location	Trials
United States	123
China	68
Korea, Republic of	16
Malaysia	12
India	10

Trials by US State

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−

Trials by US State for PREVACID 24 HR
Location	Trials
Missouri	7
California	7
Florida	6
Georgia	5
Ohio	5

Clinical Trial Progress for PREVACID 24 HR

Clinical Trial Phase

Clinical Trial Phase for PREVACID 24 HR
Clinical Trial Phase	Trials
Phase 4	18
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for PREVACID 24 HR
Clinical Trial Phase	Trials
Completed	33
Terminated	5
Unknown status	2

Clinical Trial Sponsors for PREVACID 24 HR

Sponsor Name

Sponsor Name for PREVACID 24 HR
Sponsor	Trials
Takeda	8
TAP Pharmaceutical Products Inc.	6
AstraZeneca	6

Sponsor Type

Sponsor Type for PREVACID 24 HR
Sponsor	Trials
Other	42
Industry	31
NIH	2

Prevacid 24HR: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Prevacid 24HR, containing the active ingredient lansoprazole, is a proton pump inhibitor (PPI) that has revolutionized the treatment of frequent heartburn. Since its launch as an over-the-counter (OTC) medication in 2009, it has become a significant player in the digestive health market. Here, we delve into the clinical trials, market analysis, and projections for Prevacid 24HR.

Clinical Trials and Efficacy

FDA Approval and Clinical Studies

Prevacid 24HR received FDA approval in May 2009 for the treatment of frequent heartburn, defined as heartburn occurring two or more days per week. The approval was based on extensive clinical trials that demonstrated its efficacy and safety.

• Efficacy Data: Clinical trials showed that Prevacid 24HR provides more heartburn-free days and nights compared to placebo. In two clinical trials, 88% of participants using Prevacid 24HR were satisfied with the treatment[1][2].
• Pharmacokinetics: The bioequivalence and bioavailability studies conducted by Novartis confirmed that the OTC formulation of lansoprazole is as effective as the prescription version[3].

Adverse Effects and Safety Profile

While generally well-tolerated, common adverse effects reported in clinical trials include diarrhea, headache, abdominal pain, nausea, and constipation. These side effects are typically mild and transient[2][4].

Market Analysis

Launch and Distribution

The launch of Prevacid 24HR was highly successful, with Novartis achieving an impressive 84% retail shelf presence within just four days of the launch. This was facilitated by a robust global supply and logistics network and strong retailer support[5].

Marketing Strategy

Novartis invested heavily in marketing, spending $200 million on advertising campaigns that focused on the emotional impact of heartburn on sufferers. The company leveraged various platforms, including social media, customer relationship management, and traditional advertising to drive consumer awareness and adoption[5].

Market Positioning

Prevacid 24HR competes in the PPI market against other notable brands like Prilosec (omeprazole). However, it stands out as the first and only OTC PPI in its original formulation, offering a unique selling proposition. Novartis aims to make Prevacid 24HR a top-five OTC brand in the U.S.[5].

Retail Impact

The introduction of Prevacid 24HR expanded the PPI category and generated significant incremental sales and profit for retailers. It also had a positive impact on public health by providing broader access to effective heartburn treatment[5].

Market Projections

Growth Potential

Given its strong launch and ongoing marketing efforts, Prevacid 24HR is expected to continue growing in the market. The demand for effective heartburn treatments is high, and the convenience of an OTC option is likely to attract more consumers.

Competitive Landscape

The PPI market is competitive, but Prevacid 24HR's unique positioning as the only OTC PPI in its original formulation gives it a competitive edge. As more consumers take ownership of their healthcare decisions, the demand for OTC medications like Prevacid 24HR is likely to increase[1].

Future Trends

The trend towards self-care and over-the-counter medications is expected to continue, driven by consumer preference for convenience and cost-effectiveness. This trend bodes well for Prevacid 24HR, as it aligns with consumer needs for easy access to effective treatments.

Consumer Insights

User Satisfaction

Clinical trials and post-launch data indicate high user satisfaction with Prevacid 24HR. The medication's ability to provide 24-hour relief from frequent heartburn has been a key factor in its success[1][2].

Usage Guidelines

Consumers are advised to use Prevacid 24HR as directed for 14 days, with a maximum of one 14-day course every four months, or as directed by their doctor. This ensures safe and effective use of the medication[1][2].

Key Takeaways

• Clinical Efficacy: Prevacid 24HR is clinically proven to treat frequent heartburn effectively for 24 hours.
• Market Success: The medication had a highly successful launch, achieving widespread retail presence quickly.
• Marketing Strategy: Novartis's comprehensive marketing campaign has been instrumental in driving consumer awareness and adoption.
• Growth Potential: Prevacid 24HR is expected to continue growing in the market due to its unique positioning and consumer demand.
• Consumer Satisfaction: High user satisfaction rates indicate the medication's effectiveness in treating frequent heartburn.

FAQs

What is Prevacid 24HR used for?

Prevacid 24HR is used for the treatment of frequent heartburn, which is defined as heartburn occurring two or more days per week[1][2].

How does Prevacid 24HR work?

Prevacid 24HR works by preventing acid production in the stomach, providing 24-hour relief from frequent heartburn with one pill a day[1][2].

What are the common side effects of Prevacid 24HR?

Common side effects include diarrhea, headache, abdominal pain, nausea, and constipation. These are typically mild and transient[2][4].

Can I use Prevacid 24HR for more than 14 days?

No, you should not use Prevacid 24HR for more than 14 days without consulting your doctor. You can take one 14-day course every four months, or as directed by your doctor[1][2].

Is Prevacid 24HR available in different forms?

Yes, Prevacid is available in various forms, including prescription capsules, OTC capsules (Prevacid 24HR), and dissolvable tablets (Prevacid SoluTab)[2].

How quickly does Prevacid 24HR start working?

Prevacid 24HR starts working early to treat frequent heartburn, but it may take one to four days for full effect[1].

Can children use Prevacid 24HR?

Prevacid 24HR is not recommended for children. It is intended for adult use only[2].

What is the recommended dosage of Prevacid 24HR?

The recommended dosage is one 15 mg pill per day for 14 days[1][2].

Can I take Prevacid 24HR if I have liver disease?

If you have liver disease, you should consult your doctor before taking Prevacid 24HR. The recommended daily dosage for people with liver disease is 15 mg[2].

Sources

1. Novartis Corporation Launches Prevacid(R)24HR Over-the-Counter for Full 24-Hour Frequent Heartburn Treatment. Biospace.
2. Prevacid – Uses, Side Effects, Warnings and Interactions. DrugWatch.
3. Clinical review of Prevacid 24HR OTC (NDA 022327). FDA.
4. PREVACID and PREVACID SoluTab Label. FDA.
5. OTC Medications: Novartis Consumer Healthcare. Supermarket News.