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Last Updated: March 30, 2025

CLINICAL TRIALS PROFILE FOR INDOMETHACIN SODIUM


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All Clinical Trials for INDOMETHACIN SODIUM

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00525993 ↗ Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols Unknown status Merck Sharp & Dohme Corp. Phase 4 2008-12-01 The investigators will study 2 doses of etoricoxib to prove that 60 mg once daily will be non-inferior to etoricoxib 90mg daily (for 14 days) in the treatment of acute ankle sprain in sports. The investigators objective is to discuss the point that the investigators will follow the minimal dose that is effective for the treatment of this acute condition in orthopedic.
NCT00525993 ↗ Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols Unknown status Núcleo de Estudos em Esportes e Ortopedia, Brazil Phase 4 2008-12-01 The investigators will study 2 doses of etoricoxib to prove that 60 mg once daily will be non-inferior to etoricoxib 90mg daily (for 14 days) in the treatment of acute ankle sprain in sports. The investigators objective is to discuss the point that the investigators will follow the minimal dose that is effective for the treatment of this acute condition in orthopedic.
NCT00688961 ↗ Effects of Omacor and Aspirin on Platelet Function Completed Sanford Research Early Phase 1 2007-06-01 Omacor (now Lovaza) is a pharmaceutical omega-3 fatty acid product. Omega-3 fatty acids can affect blood clotting by altering the function of the blood platelets. Aspirin can do the same. The purpose of this study is to determine the individual and combined effects of these two agents on platelet function using a whole blood method.
NCT00226122 ↗ The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal Completed University of Aarhus Phase 4 2003-01-01 Monosymptomatic nocturnal enuresis, defined as the involuntary loss of urine during the night at an age where voluntary bladder control should have been attained and on the background of normal urinary tract function, is a rather common disease of childhood with an estimated prevalence of 5-10% at tha age of 7 and a spontaneous remission rate of 15% per year. The present study consists of two phases; an in-patient phase and an ambulatory phase. In the in-patient phase we will examine the regulation of sodium and the circadian rhythm of the hormones that affect this regulation in children with enuresis nocturnal and healthy children, as well as the impact of indomethacin on renal water and electrolyte excretion. In the ambulatory phase we will examine the efficacy and safety of a treatment modality consisting of a combination of dDAVP and indomethacin in patients with severe enuresis where dDAVP as monotherapy is inadequate. A significant number of children with enuresis and nocturnal polyuria do not respond to treatment with dDAVP. If a combination treatment with dDAVP and indomethacin proves superior to dDAVP alone the regimen could readily be used in those difficult to cure cases of enuresis.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for INDOMETHACIN SODIUM

Condition Name

11110-0.100.10.20.30.40.50.60.70.80.911.1Sprains and StrainsCesarean SectionSystemic Inflammatory Response SyndromeComplication Due to Immunization[disabled in preview]
Condition Name for INDOMETHACIN SODIUM
Intervention Trials
Sprains and Strains 1
Cesarean Section 1
Systemic Inflammatory Response Syndrome 1
Complication Due to Immunization 1
[disabled in preview] 0
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Condition MeSH

21110-0.200.20.40.60.811.21.41.61.822.2Ductus Arteriosus, PatentSystemic Inflammatory Response SyndromeSprains and StrainsPancreatitis[disabled in preview]
Condition MeSH for INDOMETHACIN SODIUM
Intervention Trials
Ductus Arteriosus, Patent 2
Systemic Inflammatory Response Syndrome 1
Sprains and Strains 1
Pancreatitis 1
[disabled in preview] 0
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Clinical Trial Locations for INDOMETHACIN SODIUM

Trials by Country

+
Trials by Country for INDOMETHACIN SODIUM
Location Trials
China 2
United States 2
Brazil 2
Denmark 1
Italy 1
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Trials by US State

+
Trials by US State for INDOMETHACIN SODIUM
Location Trials
Illinois 1
South Dakota 1
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Clinical Trial Progress for INDOMETHACIN SODIUM

Clinical Trial Phase

33.3%11.1%22.2%33.3%00.811.21.41.61.822.22.42.62.833.2Phase 4Phase 2/Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for INDOMETHACIN SODIUM
Clinical Trial Phase Trials
Phase 4 3
Phase 2/Phase 3 1
Phase 2 2
[disabled in preview] 3
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Clinical Trial Status

60.0%20.0%20.0%00123456CompletedNot yet recruitingUnknown status[disabled in preview]
Clinical Trial Status for INDOMETHACIN SODIUM
Clinical Trial Phase Trials
Completed 6
Not yet recruiting 2
Unknown status 2
[disabled in preview] 0
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Clinical Trial Sponsors for INDOMETHACIN SODIUM

Sponsor Name

trials000001111111St. Justine's HospitalMerck Sharp & Dohme Corp.Alphacait, LLC[disabled in preview]
Sponsor Name for INDOMETHACIN SODIUM
Sponsor Trials
St. Justine's Hospital 1
Merck Sharp & Dohme Corp. 1
Alphacait, LLC 1
[disabled in preview] 1
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Sponsor Type

93.7%6.3%00246810121416OtherIndustry[disabled in preview]
Sponsor Type for INDOMETHACIN SODIUM
Sponsor Trials
Other 15
Industry 1
[disabled in preview] 0
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Indomethacin Sodium: Clinical Trials, Market Analysis, and Projections

Introduction to Indomethacin Sodium

Indomethacin sodium is a nonsteroidal anti-inflammatory drug (NSAID) widely used to relieve pain, reduce inflammation, and prevent swelling in various medical conditions, including arthritis, bursitis, gout, and tendonitis. Here, we will delve into the current state of clinical trials, market analysis, and future projections for indomethacin sodium.

Clinical Trials and Usage

Current Clinical Applications

Indomethacin sodium is clinically used for several specific conditions:

  • Patent Ductus Arteriosus: In premature infants, indomethacin for injection is indicated to close a hemodynamically significant patent ductus arteriosus[4].
  • Arthritis and Inflammatory Conditions: It is used to treat pain and swelling associated with arthritis, bursitis, gout, and tendonitis[2].

Ongoing and Completed Trials

Several clinical trials have been conducted to evaluate the efficacy and safety of indomethacin sodium:

  • Patent Ductus Arteriosus Trials: Studies have shown that indomethacin for injection is effective in closing patent ductus arteriosus in premature infants, although it may cause transient oliguria and elevations in serum creatinine[4].
  • Hypertension Studies: A study in elderly patients with essential hypertension found that indomethacin can increase blood pressure and lower pulse rates in patients taking certain antihypertensive medications like enalapril[3].

Safety and Side Effects

Clinical trials have highlighted several safety concerns:

  • Bleeding Risks: Indomethacin can increase the risk of bleeding when used concomitantly with anticoagulants. Studies in premature infants have shown a higher incidence of bleeding problems, including gastrointestinal and pulmonary hemorrhage[4].
  • Renal Effects: Indomethacin can cause transient reductions in renal function, as indicated by increased serum creatinine levels and transient oliguria[4].

Market Analysis

Market Dynamics

The indomethacin market is driven by several key factors:

  • Increasing Prevalence of Chronic Conditions: The rising incidence of gout and arthritis, along with a growing focus on treating these conditions, is driving the demand for indomethacin[2].
  • Pharmaceutical Industry Growth: The expanding pharmaceutical industry in developing nations is creating new growth opportunities for indomethacin[2].

Market Segmentation

The indomethacin market is segmented based on:

  • Type: Indomethacin tablets, capsules, suppositories, and other forms.
  • Age Group: Children and adults.
  • Distribution Channel: Hospital pharmacies, retail pharmacies, and online pharmacies[2].

Regional Framework

The market is analyzed across five major regions:

  • North America
  • Europe
  • Asia-Pacific (APAC)
  • Middle East and Africa (MEA)
  • South & Central America

Each region is further sub-segmented by country, providing a detailed overview of the market trends and opportunities[2].

Market Size and Growth Projections

The indomethacin market is expected to witness significant growth from 2023 to 2031, driven by the increasing demand for effective treatments for chronic inflammatory conditions. The market size is projected to grow at a substantial CAGR during this period[2].

Market Players and Strategies

Key Players

Several companies are actively involved in the indomethacin market, including Recordati Rare, Hospira, Navinta LLC, and West-ward Pharmaceuticals. These companies are focusing on both organic and inorganic growth strategies such as product launches, acquisitions, and partnerships to expand their market share[5].

Competitive Landscape

The competitive landscape of the indomethacin market is characterized by intense competition among key players. Companies are investing in research and development to improve the efficacy and safety of indomethacin formulations. SWOT analysis and market strategies of leading players are crucial in understanding the competitive dynamics[2].

Future Trends and Opportunities

Emerging Markets

The growing pharmaceutical industry in developing nations presents significant opportunities for the indomethacin market. Increasing healthcare expenditure and improving healthcare infrastructure in these regions are expected to drive market growth[2].

Technological Advancements

Advancements in drug delivery systems and formulations are likely to enhance the efficacy and safety of indomethacin. For instance, new formulations could reduce side effects and improve patient compliance.

Regulatory Environment

Changes in regulatory policies and the approval process can significantly impact the indomethacin market. Companies must stay abreast of these changes to navigate the market effectively.

PEST Analysis

A PEST analysis (Political, Economic, Social, and Technological) is essential for understanding the broader environment in which the indomethacin market operates:

  • Political Factors: Government policies and regulations can affect the approval and pricing of indomethacin.
  • Economic Factors: Economic conditions, including healthcare expenditure and reimbursement policies, influence market demand.
  • Social Factors: Increasing awareness about chronic conditions and the need for effective treatments drive market growth.
  • Technological Factors: Advances in pharmaceutical technology and drug delivery systems can enhance the market position of indomethacin[2].

Key Takeaways

  • Clinical Trials: Indomethacin sodium is used in various clinical applications, including the treatment of patent ductus arteriosus and inflammatory conditions, with ongoing trials evaluating its safety and efficacy.
  • Market Growth: The indomethacin market is expected to grow significantly due to the increasing prevalence of chronic conditions and the expanding pharmaceutical industry in developing nations.
  • Market Segmentation: The market is segmented by type, age group, and distribution channel, with a detailed regional analysis.
  • Competitive Landscape: Key players are adopting various growth strategies, and the market is characterized by intense competition.
  • Future Trends: Emerging markets, technological advancements, and regulatory changes will shape the future of the indomethacin market.

FAQs

What are the primary uses of indomethacin sodium?

Indomethacin sodium is primarily used to treat pain and swelling associated with arthritis, bursitis, gout, and tendonitis, as well as to close a hemodynamically significant patent ductus arteriosus in premature infants.

What are the potential side effects of indomethacin sodium?

Common side effects include bleeding risks, especially when used with anticoagulants, and renal effects such as transient oliguria and increased serum creatinine levels.

Which regions are expected to drive the growth of the indomethacin market?

The Asia-Pacific (APAC) region, along with other developing nations, is expected to drive market growth due to the expanding pharmaceutical industry and increasing healthcare expenditure.

What strategies are market players adopting to expand their market share?

Market players are focusing on both organic and inorganic growth strategies, including product launches, acquisitions, and partnerships.

How does indomethacin sodium affect blood pressure in patients with hypertension?

Indomethacin can increase blood pressure and lower pulse rates in patients taking certain antihypertensive medications like enalapril, but it has little effect in patients receiving amlodipine[3].

Sources

  1. Differential actions of indomethacin: clinical relevance in headache. Pain, 2021.
  2. Indomethacin Market Insights and Growth by 2031. The Insight Partners.
  3. Effect of indomethacin on blood pressure in elderly people with essential hypertension. American Journal of Hypertension, 2000.
  4. Indomethacin for Injection, USP. Pfizer Medical Information - US.
  5. Generic INDOMETHACIN SODIUM INN entry. Drug Patent Watch.

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