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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR PREVACID


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All Clinical Trials for Prevacid

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NCT00211614 ↗ Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea Withdrawn MetroHealth Medical Center N/A 2006-07-01 Obstructive Sleep Apnea (OSA) is common in modern society, affecting up to 5% of working middle-aged adults in the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

Condition Name

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

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

Trials by Country

Trials by Country for Prevacid
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
Location Trials
California 7
Missouri 7
Florida 6
Ohio 5
Pennsylvania 5
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Clinical Trial Progress for Prevacid

Clinical Trial Phase

Clinical Trial Phase for Prevacid
Clinical Trial Phase Trials
Phase 4 18
Phase 3 8
Phase 2/Phase 3 1
[disabled in preview] 15
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Clinical Trial Status

Clinical Trial Status for Prevacid
Clinical Trial Phase Trials
Completed 33
Terminated 5
Unknown status 2
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Clinical Trial Sponsors for Prevacid

Sponsor Name

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

Sponsor Type for Prevacid
Sponsor Trials
Other 42
Industry 31
NIH 2
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Prevacid: Clinical Trials, Market Analysis, and Projections

Introduction to Prevacid

Prevacid, known generically as lansoprazole, is a proton pump inhibitor (PPI) widely used for the treatment of various gastrointestinal conditions, including gastroesophageal reflux disease (GERD), erosive esophagitis, and ulcers. Here, we will delve into recent clinical trials, market analysis, and future projections for Prevacid.

Clinical Trials and Efficacy

Comparison with Vonoprazan

In a recent phase 3 clinical trial, Phathom Pharmaceuticals' vonoprazan was compared to Prevacid in the treatment of erosive esophagitis. The PHALCON-EE trial showed that vonoprazan achieved a healing rate of 93% compared to 85% for Prevacid. Although vonoprazan demonstrated faster healing in patients with moderate-to-severe disease at Week 2, it did not meet statistical significance for sustained heartburn relief by Day 3[1].

Established Indications

Prevacid has been extensively studied and is indicated for several conditions, including:

  • Erosive Esophagitis: Prevacid is effective in healing and maintaining the healing of erosive esophagitis, with treatment courses typically lasting up to 8 weeks[4].
  • GERD: It is used for the short-term treatment of symptomatic GERD and for the maintenance of healing in erosive esophagitis[4].
  • Duodenal and Gastric Ulcers: Prevacid is used in combination with antibiotics for the eradication of H. pylori to reduce the recurrence of duodenal ulcers[4].

Market Analysis

Market Size and Growth

The proton pump inhibitors (PPIs) market, which includes Prevacid, is significant and growing. As of 2024, the PPIs market is estimated to be around USD 12.70 billion and is projected to reach USD 16.32 billion by 2029, growing at a CAGR of 5.14% during the forecast period[2].

Regional Dominance

North America currently dominates the PPIs market, driven by a high prevalence of GERD in the United States, Canada, and Mexico. Approximately 40% of the U.S. population experiences GERD symptoms, with 10-20% affected on a weekly basis[2].

Market Drivers

Key factors driving the growth of the PPIs market include:

  • Increasing Prevalence of GERD: The rising incidence of GERD, partly due to lifestyle factors such as obesity, smoking, and consumption of fatty and fried foods, is a major driver[2].
  • Aging Population: The increasing geriatric population, with aging being a significant risk factor for GERD, is expected to enhance market growth[2].
  • Novel Drug Delivery Systems: The development and acceptance of new drug delivery systems are also contributing to market growth[2].

Market Challenges

COVID-19 Impact

The COVID-19 pandemic had a significant impact on the PPIs market, with studies indicating that PPI use was associated with an increased risk of COVID-19 infection and poor outcomes. However, as the pandemic subsides, the market is expected to recover and grow favorably[2].

Side Effects and Generic Competition

Prevacid, like other PPIs, is associated with side effects such as diarrhea, constipation, and nausea. Additionally, the increasing use of generic products in the market may hamper the growth of branded PPIs like Prevacid[2][4].

Future Projections

Competitive Landscape

The approval of new drugs like vonoprazan, which has shown promising results in clinical trials, may pose competition to Prevacid. Vonoprazan, licensed from Takeda, has been approved by the FDA for certain indications and is being evaluated for additional uses, including non-erosive reflux disease and eosinophilic esophagitis[1][3].

Regulatory and Pricing Considerations

By February 2025, the Centers for Medicare and Medicaid Services (CMS) are expected to announce the list of Part D drugs to be negotiated, with implementation of the negotiated prices in 2027. This could impact the pricing and market dynamics of Prevacid and other PPIs[5].

Key Takeaways

  • Clinical Efficacy: Prevacid remains effective in treating various gastrointestinal conditions, although new drugs like vonoprazan are showing promising results.
  • Market Growth: The PPIs market is expected to grow at a CAGR of 5.14% from 2024 to 2029, driven by increasing GERD prevalence and an aging population.
  • Challenges: The market faces challenges from side effects, generic competition, and the impact of the COVID-19 pandemic.
  • Future Projections: The competitive landscape is evolving with new drug approvals, and regulatory changes may affect pricing and market dynamics.

FAQs

What are the primary indications for Prevacid?

Prevacid is indicated for the treatment of erosive esophagitis, GERD, duodenal and gastric ulcers, and other conditions such as Zollinger-Ellison syndrome[4].

How does Prevacid compare to vonoprazan in clinical trials?

In the PHALCON-EE trial, vonoprazan showed a higher healing rate (93%) compared to Prevacid (85%) for erosive esophagitis, but did not meet all secondary endpoints[1].

What is the projected market size for PPIs by 2029?

The PPIs market is expected to reach USD 16.32 billion by 2029, growing at a CAGR of 5.14% from 2024 to 2029[2].

What are the major drivers of the PPIs market growth?

The increasing prevalence of GERD, an aging population, and the development of novel drug delivery systems are key drivers of the PPIs market growth[2].

How has the COVID-19 pandemic impacted the PPIs market?

The COVID-19 pandemic has been associated with an increased risk of infection and poor outcomes in patients taking PPIs, which temporarily affected market growth. However, as the pandemic subsides, the market is expected to recover[2].

Sources

  1. FierceBiotech: Phathom Pharmaceuticals' study shows its erosive esophagitis drug bests Prevacid in head-to-head trial.
  2. Mordor Intelligence: Proton Pump Inhibitors Market - Size, Share & Analysis.
  3. Phathom Pharmaceuticals: United States Securities and Exchange Commission - Form 10-K.
  4. FDA: PREVACID (lansoprazole) Label.
  5. JMCP: Drugs anticipated to be selected for the Medicare Drug Price Negotiation Program.

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