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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR INDOCIN SR


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All Clinical Trials for Indocin Sr

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002796 ↗ Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate in Advanced Colorectal Cancer Terminated National Cancer Institute (NCI) Phase 1/Phase 2 1997-05-01 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon-gamma may interfere with the growth of tumor cells and slow the growth of the tumor. Combining more than one drug with interferon-gamma may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of giving fluorouracil together with phenylbutyrate, indomethacin, and interferon-gamma and to see how well it works in treating patients with stage IV colorectal cancer
NCT00210470 ↗ A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer Completed Brooklyn ImmunoTherapeutics, LLC Phase 2 2005-07-01 This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).
NCT00210470 ↗ A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer Completed IRX Therapeutics Phase 2 2005-07-01 This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Indocin Sr

Condition Name

Condition Name for Indocin Sr
Intervention Trials
Post-ERCP Acute Pancreatitis 2
Obstetric Labor, Premature 2
Stage IV Prostate Cancer 2
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Condition MeSH

Condition MeSH for Indocin Sr
Intervention Trials
Pancreatitis 4
Obstetric Labor, Premature 3
Prostatic Neoplasms 2
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Clinical Trial Locations for Indocin Sr

Trials by Country

Trials by Country for Indocin Sr
Location Trials
United States 44
India 6
Canada 2
Denmark 1
Singapore 1
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Trials by US State

Trials by US State for Indocin Sr
Location Trials
California 5
Tennessee 3
Pennsylvania 3
Michigan 3
Massachusetts 3
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Clinical Trial Progress for Indocin Sr

Clinical Trial Phase

Clinical Trial Phase for Indocin Sr
Clinical Trial Phase Trials
Phase 4 1
Phase 3 4
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Indocin Sr
Clinical Trial Phase Trials
Completed 12
Active, not recruiting 3
Recruiting 2
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Clinical Trial Sponsors for Indocin Sr

Sponsor Name

Sponsor Name for Indocin Sr
Sponsor Trials
National Cancer Institute (NCI) 3
Brooklyn ImmunoTherapeutics, LLC 3
IRX Therapeutics 3
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Sponsor Type

Sponsor Type for Indocin Sr
Sponsor Trials
Other 37
Industry 7
NIH 4
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Indocin SR: Clinical Trials, Market Analysis, and Projections

Introduction to Indocin SR

Indocin SR, the extended-release formulation of indomethacin, is a nonsteroidal anti-inflammatory drug (NSAID) widely used to relieve pain and swelling in patients suffering from arthritis, bursitis, gout, tendonitis, and other inflammatory conditions. Here, we will delve into the current clinical trials, market analysis, and future projections for Indocin SR.

Clinical Trials: Ketotifen and Indomethacin Combination for COVID-19

One of the recent and significant clinical trials involving indomethacin is the combination treatment with ketotifen for COVID-19 patients. This randomized, double-blind, placebo-controlled study aims to evaluate the safety and effectiveness of this combination in improving COVID-19 symptoms.

Objectives and Hypotheses

  • The primary objective is to assess the safety of the ketotifen and indomethacin combination in COVID-19 patients, hypothesizing no increase in adverse events or disease severity[1][4].
  • The secondary objective is to investigate the effectiveness of this combination in improving respiratory function and resolving COVID-19 symptoms, hypothesizing an improvement in shortness of breath and a shorter duration of respiratory symptoms[1][4].

Study Design

  • The study involves 150 patients aged 18-75 years, randomized 2:1 to receive either the ketotifen/indomethacin combination or a placebo.
  • Patients must meet specific inclusion and exclusion criteria, including testing positive for COVID-19 and presenting with at least two symptoms indicative of COVID-19 infection[1][4].

Market Analysis of Indomethacin

Market Size and Growth

The global indomethacin market is expected to witness significant growth from 2024 to 2031. The market size in 2023 was valued at several million dollars, with a projected compound annual growth rate (CAGR) of several percent over the forecast period[2][5].

Market Drivers

  • The increasing prevalence of gout and arthritis, along with a growing focus on treating chronic conditions that cause pain and swelling, are key drivers of the indomethacin market[2].
  • The expansion of the pharmaceutical industry in developing nations also contributes to market growth[2].

Market Segmentation

The indomethacin market is segmented by type (tablets, capsules, suppositories), age group (children, adults), and distribution channel (hospital pharmacies, retail pharmacies, online pharmacies)[2].

Regional Framework

The market is analyzed across major regions including North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region is further sub-segmented by country to provide a detailed overview of the market dynamics[2][5].

Safety and Efficacy of Indomethacin

Clinical Trials Experience

Indomethacin has been extensively studied in various clinical settings. For instance, a gastroscopic study in healthy subjects showed a higher number of gastric mucosal abnormalities in the indomethacin group, highlighting the need for careful dosage management[3].

Adverse Reactions

Indomethacin can cause serious adverse reactions, particularly in the elderly. Common adverse effects include gastrointestinal issues, and the drug should be used with caution when combined with other NSAIDs, salicylates, cyclosporine, and pemetrexed[3].

Dosage and Administration

The dosage of indomethacin varies depending on the condition being treated. For acute painful shoulder conditions like bursitis and tendinitis, the usual dosage is 75-150 mg daily in 3 or 4 divided doses. The treatment is typically discontinued after the signs and symptoms of inflammation have been controlled for several days[3].

Market Projections

Forecast Period

The indomethacin market is forecasted from 2024 to 2031, with historical data from 2021 to 2023 providing a baseline for the projections. The report includes revenue forecasts, company analyses, industry landscapes, growth factors, and trends[5].

Competitive Landscape

The market report provides an overview of the competitive landscape, including key statistics on the market status of leading players in the indomethacin market. It also highlights trends and opportunities within the market[2][5].

PEST and SWOT Analysis

The report includes a detailed PEST (Political, Economic, Social, and Technological) analysis and SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis for all major regions. This helps in understanding the market dynamics and potential future directions[2][5].

Key Takeaways

  • Clinical Trials: The combination of ketotifen and indomethacin is being studied for its safety and efficacy in COVID-19 patients, with promising hypotheses on improving respiratory symptoms.
  • Market Growth: The indomethacin market is expected to grow significantly due to increasing prevalence of arthritis and gout, and expanding pharmaceutical industries in developing nations.
  • Safety and Efficacy: Indomethacin requires careful management due to potential adverse reactions, especially in the elderly and when combined with other medications.
  • Market Projections: The market is forecasted to grow from 2024 to 2031, with detailed analyses of the competitive landscape, PEST and SWOT analyses, and regional market dynamics.

FAQs

What is the primary objective of the clinical trial involving ketotifen and indomethacin for COVID-19?

The primary objective is to evaluate the safety of the ketotifen and indomethacin combination in COVID-19 patients, ensuring no increase in adverse events or disease severity[1][4].

What are the common adverse reactions associated with indomethacin?

Common adverse reactions include gastrointestinal issues, and the drug should be used with caution, especially in the elderly and when combined with other NSAIDs, salicylates, cyclosporine, and pemetrexed[3].

What is the expected growth rate of the indomethacin market from 2024 to 2031?

The indomethacin market is expected to witness a significant compound annual growth rate (CAGR) from 2024 to 2031, driven by increasing prevalence of gout and arthritis and the expansion of the pharmaceutical industry in developing nations[2][5].

How is the indomethacin market segmented?

The market is segmented by type (tablets, capsules, suppositories), age group (children, adults), and distribution channel (hospital pharmacies, retail pharmacies, online pharmacies)[2].

What regions are covered in the indomethacin market analysis?

The market analysis covers North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America, with further sub-segmentation by country[2][5].

Sources

  1. CTV Veeva: Ketotifen and Indomethacin Combination Treatment Clinical Trial for COVID-19.
  2. The Insight Partners: Indomethacin Market Insights and Growth by 2031.
  3. RxList: Indocin SR (Indomethacin Extended Release Capsules).
  4. Reagan-Udall Foundation: Ketotifen and Indomethacin Combination Treatment Clinical Trial for COVID-19.
  5. Cognitive Market Research: Indomethacin Market Report 2024 (Global Edition).

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