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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR IBUPROFEN AND FAMOTIDINE


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All Clinical Trials for Ibuprofen And Famotidine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00450216 ↗ Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment Completed Horizon Pharma Ireland, Ltd., Dublin Ireland Phase 3 2007-03-01 The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
NCT00450658 ↗ Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers Completed Horizon Pharma Ireland, Ltd., Dublin Ireland Phase 3 2007-03-01 The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
NCT00613106 ↗ Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216) Completed Horizon Pharma Ireland, Ltd., Dublin Ireland Phase 3 2007-09-01 The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
NCT00984815 ↗ Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment Completed Horizon Pharma Ireland, Ltd., Dublin Ireland Phase 3 2009-09-01 The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.
NCT01563185 ↗ Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis Completed Pediatric Rheumatology Collaborative Study Group Phase 4 2012-04-01 The primary objective of this Phase 4, multi-center, open-label study is to evaluate the safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10 years to 16 years, 11 months, treated up to 24 weeks. The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients and to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11 months receiving DUEXIS for up to 24 weeks.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ibuprofen And Famotidine

Condition Name

Condition Name for Ibuprofen And Famotidine
Intervention Trials
Chronic Soft Tissue Pain 2
Osteoarthritis 2
Rheumatoid Arthritis 2
Chronic Low Back Pain 2
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Condition MeSH

Condition MeSH for Ibuprofen And Famotidine
Intervention Trials
Osteoarthritis 2
Nociceptive Pain 2
Low Back Pain 2
Back Pain 2
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Clinical Trial Locations for Ibuprofen And Famotidine

Trials by Country

Trials by Country for Ibuprofen And Famotidine
Location Trials
United States 9
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Trials by US State

Trials by US State for Ibuprofen And Famotidine
Location Trials
Texas 2
Pennsylvania 2
North Carolina 1
Massachusetts 1
Louisiana 1
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Clinical Trial Progress for Ibuprofen And Famotidine

Clinical Trial Phase

Clinical Trial Phase for Ibuprofen And Famotidine
Clinical Trial Phase Trials
Phase 4 2
Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Ibuprofen And Famotidine
Clinical Trial Phase Trials
Completed 5
Terminated 1
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Clinical Trial Sponsors for Ibuprofen And Famotidine

Sponsor Name

Sponsor Name for Ibuprofen And Famotidine
Sponsor Trials
Horizon Pharma Ireland, Ltd., Dublin Ireland 5
Pediatric Rheumatology Collaborative Study Group 1
Duke University 1
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Sponsor Type

Sponsor Type for Ibuprofen And Famotidine
Sponsor Trials
Industry 5
Other 2
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Ibuprofen and Famotidine: Clinical Trials, Market Analysis, and Projections

Introduction to Ibuprofen and Famotidine

Ibuprofen and famotidine, combined in medications like DUEXIS, are used to relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis, while also reducing the risk of developing upper gastrointestinal ulcers associated with ibuprofen use.

Clinical Trials Overview

Indications and Usage

Clinical trials for ibuprofen and famotidine combination tablets, such as DUEXIS, have primarily focused on patients with rheumatoid arthritis and osteoarthritis. These trials have demonstrated the efficacy of this combination in relieving pain and inflammation, as well as in reducing the incidence of gastric and duodenal ulcers in patients taking ibuprofen for these conditions[1][4].

Patient Demographics

The clinical trials mainly enrolled patients under the age of 65 without a prior history of gastrointestinal ulcers. Controlled trials did not extend beyond six months, providing a clear understanding of the short-term benefits and risks of this medication[1][4].

Contraindications and Warnings

It is crucial to note that ibuprofen and famotidine are contraindicated in the setting of coronary artery bypass graft (CABG) surgery due to the increased risk of serious gastrointestinal adverse events. Patients with a history of asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs should also avoid this medication[4].

Adverse Events

Common adverse reactions reported in clinical trials include nausea, diarrhea, constipation, upper abdominal pain, and headache. Serious adverse events such as hepatotoxicity, renal injury, and ophthalmological effects (like blurred vision) have also been observed, necessitating careful monitoring and discontinuation if symptoms persist[1][4].

Market Analysis

Current Market Size

The global ibuprofen market, which includes ibuprofen and famotidine combinations, was valued at approximately $100 million in 2023. This market is expected to grow significantly over the next decade, driven by several key factors[2][5].

Growth Drivers

  • Rising Prevalence of Chronic Diseases: The increasing incidence of arthritis, cardiovascular conditions, and other chronic diseases is a major driver of the ibuprofen market. As populations age and lifestyles become more sedentary, the demand for effective pain management solutions like ibuprofen is on the rise[2][5].
  • Accessibility and Awareness: The widespread availability of ibuprofen as an over-the-counter medication and its reputation for quick and reliable pain relief contribute to its high adoption rates. Public awareness about the benefits and risks of ibuprofen also plays a significant role in market growth[2][5].
  • Strategic Initiatives by Key Players: Pharmaceutical companies are engaging in product launches, approvals, and partnerships, which are adding to the market's growth. For example, the launch of generic versions of DUEXIS by companies like Endo International and Lupin has expanded the market reach[1][3].

Market Projections

The global ibuprofen market is projected to reach $213.6 million by 2033, growing at a CAGR of 7.9% from 2024 to 2033. Another forecast suggests the market will reach $111.41 million by 2031, growing at a CAGR of 2.40% from 2024 to 2031, though this figure seems to be more conservative and might pertain to a specific segment of the market[2][5].

Regional Market Trends

North America currently dominates the market share due to the high adoption of ibuprofen and well-developed healthcare infrastructure. However, the Asia-Pacific region is anticipated to witness substantial growth driven by increasing healthcare expenditure, low manufacturing costs, and an expanding geriatric population prone to chronic diseases[2][3].

Market Segmentation

By Application

The ibuprofen market is segmented into various applications, including:

  • Rheumatoid Arthritis and Osteoarthritis: This segment is expected to hold the largest revenue share due to the high demand for ibuprofen in treating rheumatic musculoskeletal disorders.
  • Cancer: Ibuprofen is also used in cancer treatment, contributing to the market's expansion.
  • Pain/Fever/Dysmenorrhea: Its use in managing pain, fever, and dysmenorrhea further fuels market growth.
  • Inflammatory Diseases: Ibuprofen's anti-inflammatory properties make it a popular choice for various inflammatory diseases.
  • Headache: It is widely used for headache relief, adding to its market demand[5].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the ibuprofen market, particularly the active pharmaceutical ingredient (API) segment. The increased utility of ibuprofen for self-medication during the pandemic led to temporary shortages. However, as the pandemic's impact waned, the market saw a slight decline, which is expected to recover as manufacturing capacities expand globally[3].

Key Players and Competitive Landscape

The market is fragmented with numerous global and regional companies holding significant market shares. Key players such as Solara Active Pharma Sciences Ltd, Abbott Laboratories, Pfizer Inc., and BASF SE are actively involved in expanding their ibuprofen API offerings, further fueling market growth[2][3].

Conclusion

The combination of ibuprofen and famotidine is a significant player in the pain management market, particularly for patients with rheumatoid arthritis and osteoarthritis. With a strong clinical trial backing and a growing market driven by the increasing prevalence of chronic diseases, this medication is poised for continued growth.

Key Takeaways

  • Clinical Efficacy: Ibuprofen and famotidine combination tablets are effective in relieving pain and inflammation while reducing the risk of gastrointestinal ulcers.
  • Market Growth: The global ibuprofen market is expected to grow significantly, driven by the rising prevalence of chronic diseases and strategic initiatives by key players.
  • Regional Trends: North America currently dominates the market, but the Asia-Pacific region is expected to see substantial growth.
  • Applications: The medication is widely used for various conditions, including rheumatoid arthritis, osteoarthritis, cancer, and headache relief.

FAQs

What are the primary indications for ibuprofen and famotidine combination tablets?

The primary indications are for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis, and to decrease the risk of developing upper gastrointestinal ulcers in patients taking ibuprofen for these conditions[1][4].

What are the common adverse reactions associated with ibuprofen and famotidine?

Common adverse reactions include nausea, diarrhea, constipation, upper abdominal pain, and headache. Serious adverse events such as hepatotoxicity, renal injury, and ophthalmological effects can also occur[1][4].

How is the global ibuprofen market projected to grow?

The global ibuprofen market is projected to reach $213.6 million by 2033, growing at a CAGR of 7.9% from 2024 to 2033[2].

What regions are expected to drive the growth of the ibuprofen market?

North America currently dominates the market, but the Asia-Pacific region is anticipated to witness substantial growth due to increasing healthcare expenditure and an expanding geriatric population[2][3].

What are the key factors driving the growth of the ibuprofen market?

Key factors include the rising prevalence of chronic diseases, growing awareness of over-the-counter pain relief medications, and strategic initiatives by key players in the pharmaceutical industry[2][3][5].

Sources

  1. Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of Duexis - PR Newswire
  2. Ibuprofen Market Statistics, Growth Drivers | Forecast - 2033 - Allied Market Research
  3. Ibuprofen API Market Size | Mordor Intelligence
  4. DUEXIS (ibuprofen and famotidine) Label - FDA
  5. Ibuprofen Market Size, Share, Scope, Trends, Growth & Forecast - Verified Market Research

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