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Last Updated: March 20, 2025

CLINICAL TRIALS PROFILE FOR PREVACID IV


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All Clinical Trials for Prevacid Iv

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00211614 ↗ Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea Withdrawn MetroHealth Medical Center N/A 2006-07-01 Obstructive Sleep Apnea (OSA) is common in modern society, affecting up to 5% of working middle-aged adults in the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.
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 ®
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Prevacid Iv

Condition Name

Condition Name for Prevacid Iv
Intervention Trials
Healthy 9
Gastroesophageal Reflux 6
Erosive Esophagitis 4
Asthma 3
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Condition MeSH

Condition MeSH for Prevacid Iv
Intervention Trials
Gastroesophageal Reflux 14
Esophagitis 6
Laryngopharyngeal Reflux 3
Ulcer 3
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Clinical Trial Locations for Prevacid Iv

Trials by Country

Trials by Country for Prevacid Iv
Location Trials
United States 123
China 68
Korea, Republic of 16
Malaysia 12
Canada 10
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Trials by US State

Trials by US State for Prevacid Iv
Location Trials
California 7
Missouri 7
Florida 6
Georgia 5
Ohio 5
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Clinical Trial Progress for Prevacid Iv

Clinical Trial Phase

Clinical Trial Phase for Prevacid Iv
Clinical Trial Phase Trials
Phase 4 18
Phase 3 8
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Prevacid Iv
Clinical Trial Phase Trials
Completed 33
Terminated 5
Withdrawn 2
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Clinical Trial Sponsors for Prevacid Iv

Sponsor Name

Sponsor Name for Prevacid Iv
Sponsor Trials
Takeda 8
AstraZeneca 6
TAP Pharmaceutical Products Inc. 6
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Sponsor Type

Sponsor Type for Prevacid Iv
Sponsor Trials
Other 42
Industry 31
NIH 2
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Prevacid IV (Lansoprazole for Injection): Clinical Trials, Market Analysis, and Projections

Introduction

Prevacid IV, or lansoprazole for injection, is a proton pump inhibitor (PPI) used to treat various gastrointestinal disorders, including erosive esophagitis, especially when patients are unable to take oral formulations. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Safety Profile

Clinical Safety Experience

Clinical trials involving Prevacid IV have shown that the treatment is generally well-tolerated. In four U.S. trials with 161 subjects, the most common treatment-related adverse events reported were headache (1.0%), injection site pain (1.0%), injection site reaction (1.0%), and nausea (1.3%)[1][5].

Adverse Events

Less common adverse events, occurring in less than 1% of subjects, included abdominal pain, vasodilatation, diarrhea, dyspepsia, vomiting, dizziness, paresthesia, rash, and taste perversion. No new adverse drug reactions were reported with the intravenous formulation that had not been previously associated with the oral formulations[1][5].

Long-Term and Oral Formulations

Over 10,000 patients have been treated with oral Prevacid in Phase 2 and Phase 3 clinical trials, and the treatment has been well-tolerated in both short-term and long-term trials. Common adverse events in oral formulations include abdominal pain, constipation, diarrhea, and nausea, with diarrhea being more prevalent in higher doses[1].

Market Analysis

Market Trends

The proton pump inhibitor (PPI) market has seen significant shifts with the introduction of generic versions of popular PPIs. Generic lansoprazole, the active ingredient in Prevacid, entered the market in late 2009 and quickly gained a large share of the brand-name Prevacid supply. This trend has continued, with generic PPIs, including lansoprazole, pantoprazole, and omeprazole, gaining market share at the expense of brand-name drugs[2].

Generic Substitution

The generic dispensing rate (GDR) for PPIs increased by 8.0% due to the availability of generic lansoprazole, pantoprazole, and omeprazole. This trend is expected to continue, reducing the overall cost in the PPI class and potentially making statins the highest gross cost class in the future[2].

Regional Insights

The North American region is expected to dominate the lansoprazole market due to a high prevalence of gastroesophageal reflux disease (GERD) in the United States. The market size for lansoprazole is projected to grow at a CAGR of 5.8% from 2024 to 2030, reaching nearly $2.81 billion by 2030[3].

Market Projections

Growth and Revenue

The global lansoprazole market, valued at $1.89 billion in 2023, is expected to grow at a CAGR of 5.8% through 2024 to 2030. This growth is driven by the increasing demand for sustained-release proton pump inhibitor medicines, particularly in regions with high GERD prevalence like North America[3].

Route of Administration

The oral route of administration is expected to hold the largest market share due to patient preference for capsule formulations, the low cost of oral capsules, and the increasing number of manufacturers supplying lansoprazole in capsule forms[3].

Competitive Landscape

The introduction of new PPIs, such as vonoprazan, may impact the market share of existing drugs like lansoprazole. Vonoprazan, approved under the brand names VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, is being developed for various indications, including GERD and H. pylori infection, and may offer competitive advantages in the future[4].

Key Takeaways

  • Prevacid IV is well-tolerated with a manageable side effect profile.
  • The PPI market is heavily influenced by generic substitutions, which have reduced the market share of brand-name drugs.
  • The North American region is a significant market for lansoprazole due to high GERD prevalence.
  • The global lansoprazole market is projected to grow at a CAGR of 5.8% from 2024 to 2030.
  • Oral formulations are expected to dominate the market due to patient preference and cost factors.

Frequently Asked Questions

1. What are the common side effects of Prevacid IV?

Common side effects include headache, injection site pain, injection site reaction, and nausea. Less common side effects can include abdominal pain, diarrhea, dyspepsia, and others[1][5].

2. How has the introduction of generic lansoprazole affected the market?

The introduction of generic lansoprazole has significantly increased the generic dispensing rate, reducing the market share of brand-name Prevacid and other PPIs. This trend is expected to continue, driving down costs in the PPI class[2].

3. What is the projected market size for lansoprazole by 2030?

The global lansoprazole market is expected to reach nearly $2.81 billion by 2030, growing at a CAGR of 5.8% from 2024 to 2030[3].

4. Which region is expected to dominate the lansoprazole market?

The North American region is expected to dominate the lansoprazole market due to the high prevalence of GERD in the United States[3].

5. Are there any new PPIs that could impact the market share of lansoprazole?

Yes, new PPIs like vonoprazan, approved under the brand names VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, are being developed and may offer competitive advantages in the future, potentially impacting the market share of lansoprazole[4].

Cited Sources:

  1. RxList - Prevacid I.V. (Lansoprazole for Injection): Side Effects, Uses...
  2. Pharmacy Times - Proton Pump Inhibitor Drug Utilization and Cost Trends
  3. Maximize Market Research - Lansoprazole Market: Global Industry Analysis and Forecast
  4. Phathom Pharma - United States Securities and Exchange Commission - Form 10-K
  5. FDA - PREVACID® IV (lansoprazole) for Injection 30 mg/vial Rx only

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