You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2025

CLINICAL TRIALS PROFILE FOR PREVACID IV


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for PREVACID IV

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00211614 ↗ Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea Withdrawn MetroHealth Medical Center N/A 2006-07-01 Obstructive Sleep Apnea (OSA) is common in modern society, affecting up to 5% of working middle-aged adults in the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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for PREVACID IV

Condition Name

96400123456789HealthyGastroesophageal RefluxErosive Esophagitis[disabled in preview]
Condition Name for PREVACID IV
Intervention Trials
Healthy 9
Gastroesophageal Reflux 6
Erosive Esophagitis 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

1463002468101214Gastroesophageal RefluxEsophagitisLaryngopharyngeal Reflux[disabled in preview]
Condition MeSH for PREVACID IV
Intervention Trials
Gastroesophageal Reflux 14
Esophagitis 6
Laryngopharyngeal Reflux 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
India 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

+
Trials by US State for PREVACID IV
Location Trials
Missouri 7
California 7
Florida 6
Pennsylvania 5
Georgia 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for PREVACID IV

Clinical Trial Phase

66.7%29.6%0024681012141618Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for PREVACID IV
Clinical Trial Phase Trials
Phase 4 18
Phase 3 8
Phase 2/Phase 3 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

82.5%12.5%5.0%005101520253035CompletedTerminatedUnknown status[disabled in preview]
Clinical Trial Status for PREVACID IV
Clinical Trial Phase Trials
Completed 33
Terminated 5
Unknown status 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for PREVACID IV

Sponsor Name

trials012345678TakedaAstraZenecaTAP Pharmaceutical Products Inc.[disabled in preview]
Sponsor Name for PREVACID IV
Sponsor Trials
Takeda 8
AstraZeneca 6
TAP Pharmaceutical Products Inc. 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

56.0%41.3%0051015202530354045OtherIndustryNIH[disabled in preview]
Sponsor Type for PREVACID IV
Sponsor Trials
Other 42
Industry 31
NIH 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.