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Last Updated: March 24, 2025

CLINICAL TRIALS PROFILE FOR LANSOPRAZOLE; NAPROXEN


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All Clinical Trials for LANSOPRAZOLE; NAPROXEN

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Fundação de Amparo à Pesquisa do Estado de São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Federal University of São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02128490 ↗ Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment Completed Takeda Phase 2 2014-05-01 The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80 mg IR, respectively, in gout participants with moderate renal impairment.
NCT02139046 ↗ Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout Completed Takeda Phase 3 2014-04-01 The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80 mg IR, respectively, in participants with gout.
NCT00175032 ↗ A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin Completed Takeda Phase 3 2003-07-01 The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in participants with osteoarthritis taking low dose aspirin.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for LANSOPRAZOLE; NAPROXEN

Condition Name

21110-0.200.20.40.60.811.21.41.61.822.2GoutOsteoarthritisPeptic UlcerAtrial Fibrillation[disabled in preview]
Condition Name for LANSOPRAZOLE; NAPROXEN
Intervention Trials
Gout 2
Osteoarthritis 1
Peptic Ulcer 1
Atrial Fibrillation 1
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Condition MeSH

21110-0.200.20.40.60.811.21.41.61.822.2GoutRenal InsufficiencyAtrial FibrillationUlcer[disabled in preview]
Condition MeSH for LANSOPRAZOLE; NAPROXEN
Intervention Trials
Gout 2
Renal Insufficiency 1
Atrial Fibrillation 1
Ulcer 1
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Clinical Trial Locations for LANSOPRAZOLE; NAPROXEN

Trials by Country

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Trials by Country for LANSOPRAZOLE; NAPROXEN
Location Trials
United States 68
Brazil 1
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Trials by US State

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Trials by US State for LANSOPRAZOLE; NAPROXEN
Location Trials
Missouri 2
Michigan 2
Massachusetts 2
Louisiana 2
Kentucky 2
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Clinical Trial Progress for LANSOPRAZOLE; NAPROXEN

Clinical Trial Phase

25.0%50.0%25.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for LANSOPRAZOLE; NAPROXEN
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2 1
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Clinical Trial Status

100.0%000.511.522.533.54Completed[disabled in preview]
Clinical Trial Status for LANSOPRAZOLE; NAPROXEN
Clinical Trial Phase Trials
Completed 4
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Clinical Trial Sponsors for LANSOPRAZOLE; NAPROXEN

Sponsor Name

trials0112233TakedaFundação de Amparo à Pesquisa do Estado de São PauloFederal University of São Paulo[disabled in preview]
Sponsor Name for LANSOPRAZOLE; NAPROXEN
Sponsor Trials
Takeda 3
Fundação de Amparo à Pesquisa do Estado de São Paulo 1
Federal University of São Paulo 1
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Sponsor Type

60.0%40.0%000.511.522.53IndustryOther[disabled in preview]
Sponsor Type for LANSOPRAZOLE; NAPROXEN
Sponsor Trials
Industry 3
Other 2
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Clinical Trials, Market Analysis, and Projections for Lansoprazole and Naproxen

Introduction

Lansoprazole and naproxen are two widely used medications, each targeting different health conditions. Lansoprazole is a proton pump inhibitor (PPI) used primarily for gastrointestinal issues, while naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used for pain and inflammation. Here, we will delve into recent clinical trials, market analysis, and future projections for these drugs.

Clinical Trials Update for Lansoprazole

PHALCON-EE Trial

A significant clinical trial involving lansoprazole is the PHALCON-EE trial conducted by Phathom Pharmaceuticals. This pivotal Phase 3 trial compared vonoprazan, a new PPI, to lansoprazole in the treatment of erosive esophagitis (EE)[1].

  • Healing Phase: Vonoprazan 20 mg was compared to lansoprazole 30 mg for up to 8 weeks. Vonoprazan demonstrated superior healing rates in patients with moderate-to-severe disease at Week 2 and overall healing rates by Week 8.
  • Maintenance Phase: Vonoprazan 10 mg and 20 mg were compared to lansoprazole 15 mg for the maintenance of healing over 24 weeks. Vonoprazan showed superior maintenance of healing in all patients and those with moderate-to-severe disease.
  • Heartburn Symptom Relief: Both phases evaluated heartburn symptoms, with vonoprazan showing better relief compared to lansoprazole.

Idiopathic Pulmonary Fibrosis Trial

Another trial involving lansoprazole is focused on treating people with idiopathic pulmonary fibrosis (IPF). This study aims to assess the effect of adding lansoprazole to the treatment regimen of IPF patients. Participants will receive either lansoprazole or a placebo for 12 months, with evaluations on coughing, breathlessness, and other symptoms[5].

Clinical Trials Update for Naproxen

Naproxen and Diphenhydramine Combination Trial

A recent clinical trial involves the combination of naproxen sodium and diphenhydramine hydrochloride. This multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the safety and tolerability of this combination in an over-the-counter (OTC) population. The trial compares the combination to a placebo over a 10-day period[3].

ART26.12 vs. Naproxen in Osteoarthritis

Artelo Biosciences has conducted preclinical studies comparing their novel FABP5 inhibitor, ART26.12, to naproxen in treating osteoarthritis (OA) pain. ART26.12 showed superior symptom relief and a clear dose-response relationship in a surgical rodent OA model, outperforming naproxen in weight-bearing outcomes[2].

Market Analysis for Lansoprazole

Proton Pump Inhibitors Market

The global proton pump inhibitors (PPIs) market, which includes lansoprazole, is valued at around $2.8 billion as of 2022 and is expected to grow at a CAGR of 5.2% to reach $4.9 billion by 2033. Omeprazole currently dominates the market, but lansoprazole remains a significant player due to its efficacy in reducing stomach acid production and relieving acid reflux and heartburn symptoms[4].

  • Market Share: While omeprazole holds a market share of around 28.5%, lansoprazole and other PPIs continue to be widely prescribed and used.
  • Oral Route Dominance: The oral route of administration for PPIs, including lansoprazole, dominates the market with a significant share of 66.3% as of 2022.

Market Analysis for Naproxen

Nonsteroidal Anti-Inflammatory Drugs Market

Naproxen is part of the broader NSAIDs market, which is driven by the increasing demand for pain management solutions. While specific market figures for naproxen are not as readily available as those for PPIs, the overall NSAIDs market is substantial and continues to grow.

  • Competition: Naproxen faces competition from other NSAIDs and emerging non-opioid pain treatments like ART26.12, which may alter market dynamics in the future.
  • Generic Availability: Naproxen, being available in generic forms, maintains its market presence due to its cost-effectiveness and widespread use.

Future Projections

Lansoprazole

Given the ongoing trials and the established efficacy of lansoprazole, it is expected to remain a key player in the PPI market. However, the emergence of new PPIs like vonoprazan may challenge its market share. The growing demand for effective acid-suppressing medications will continue to drive the market, but lansoprazole's position may be influenced by the outcomes of comparative trials.

Naproxen

Naproxen's future in the NSAIDs market will be shaped by the development of new pain management treatments. The FDA clearance for ART26.12 and its promising preclinical results indicate a potential shift towards non-opioid, non-addictive alternatives. Naproxen's market presence will likely be maintained due to its established use and generic availability, but it may face increased competition from newer treatments.

Key Takeaways

  • Lansoprazole: Remains a significant player in the PPI market, but faces competition from new PPIs like vonoprazan.
  • Naproxen: Continues to be widely used, but may face competition from emerging non-opioid pain treatments.
  • Market Growth: Both PPI and NSAID markets are expected to grow, driven by increasing demand for effective treatments.
  • Clinical Trials: Ongoing and future trials will shape the market positions of both lansoprazole and naproxen.

FAQs

What is the current market value of the proton pump inhibitors market?

The global proton pump inhibitors market is currently valued at around $2.8 billion as of 2022 and is expected to reach $4.9 billion by 2033[4].

How does vonoprazan compare to lansoprazole in treating erosive esophagitis?

Vonoprazan demonstrated superior healing rates and maintenance of healing compared to lansoprazole in the PHALCON-EE trial[1].

What is the status of ART26.12 in clinical trials?

ART26.12 has received FDA clearance for its first-in-human Phase 1 single ascending dose study, with initial results expected in the first half of 2025[2].

What are the potential side effects of the naproxen and diphenhydramine combination?

The trial evaluating this combination focuses on safety and tolerability, with participants monitored for any side effects over a 10-day period[3].

How does the market share of omeprazole compare to other PPIs like lansoprazole?

Omeprazole holds a market share of around 28.5%, while other PPIs, including lansoprazole, also maintain significant market presence[4].

Sources

  1. Phathom Pharmaceuticals Announces Positive Topline Results from PHALCON-EE Pivotal Phase 3 Erosive Esophagitis Trial - GlobeNewswire
  2. Artelo Biosciences Announces Promising New Data on Novel Non-Opioid Treatment Approach for Osteoarthritis Pain - Stock Titan
  3. Safety Trial of Naproxen Sodium/ Diphenhydramine (MUST) - Bayer Clinical Trials Explorer
  4. Proton Pump Inhibitors Market Share & Forecast by 2033 - Future Market Insights
  5. Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole - CenterWatch

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