CLINICAL TRIALS PROFILE FOR INDOMETHACIN

All Clinical Trials for indomethacin

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
NCT00004778 ↗	Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery	Completed	Children's Hospital of Philadelphia	Phase 3	1993-08-01	OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
NCT00004778 ↗	Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1993-08-01	OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
NCT00002535 ↗	Indomethacin Plus Biological Therapy in Treating Patients With Advanced Melanoma	Completed	St. Luke's Medical Center	Phase 2	1993-07-01	RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Combining biological therapies with indomethacin and cyclophosphamide may kill more tumor cells. PURPOSE: Phase II trial to compare the effectiveness of indomethacin and biological therapy with or without cyclophosphamide in treating patients who have advanced melanoma that has not responded to previous therapy.
NCT00000494 ↗	Management of Patent Ductus in Premature Infants	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1978-09-01	To evaluate the effects (up to one year of age) of indomethacin on the clinical course of patent ductus arteriosus (PDA) in premature infants (24 hours old or less) and to assess the relative merits of indomethacin and surgery in infants with persistent respiratory distress who were not treated early with indomethacin. Two concurrent trials were performed.

Clinical Trial Conditions for indomethacin

Condition Name

Condition Name for indomethacin
Intervention	Trials
Patent Ductus Arteriosus	15
Post-ERCP Acute Pancreatitis	10
Healthy	7
Obstetric Labor, Premature	5

Condition MeSH

Condition MeSH for indomethacin
Intervention	Trials
Pancreatitis	34
Ductus Arteriosus, Patent	25
Premature Birth	17
Obstetric Labor, Premature	12

Clinical Trial Locations for indomethacin

Trials by Country

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Trials by Country for indomethacin
Location	Trials
United States	279
Canada	33
China	27
India	19
Taiwan	9

Trials by US State

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Trials by US State for indomethacin
Location	Trials
California	17
Texas	16
Ohio	14
Michigan	14
New York	12

Clinical Trial Progress for indomethacin

Clinical Trial Phase

Clinical Trial Phase for indomethacin
Clinical Trial Phase	Trials
Phase 4	39
Phase 3	34
Phase 2/Phase 3	11

Clinical Trial Status

Clinical Trial Status for indomethacin
Clinical Trial Phase	Trials
Completed	95
Unknown status	25
Recruiting	17

Clinical Trial Sponsors for indomethacin

Sponsor Name

Sponsor Name for indomethacin
Sponsor	Trials
Air Force Military Medical University, China	5
Iroko Pharmaceuticals, LLC	4
National Cancer Institute (NCI)	4

Sponsor Type

Sponsor Type for indomethacin
Sponsor	Trials
Other	217
Industry	48
NIH	16

Indomethacin: Clinical Trials, Market Analysis, and Projections

Introduction to Indomethacin

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. It works by blocking substances in the body that cause inflammation, thereby preventing pain and swelling.

Clinical Trials Update

Post-ERCP Pancreatitis Prevention

Recent clinical trials have raised significant questions about the efficacy of indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP).

• A randomized, placebo-controlled, double-blind clinical trial conducted at Dartmouth-Hitchcock Medical Center found that a single dose of rectal indomethacin (100 mg) before ERCP did not significantly reduce the occurrence of PEP compared to a placebo. The trial, which included patients at both high and average risk for PEP, was halted early due to statistical futility in showing any significant difference between indomethacin and placebo[1].
• Another study published in 2024 compared the use of rectal indomethacin alone versus the combination of indomethacin and a prophylactic pancreatic stent in high-risk patients. The results indicated that while indomethacin alone was not as effective as the combination, the addition of a pancreatic stent significantly reduced the incidence of PEP. This suggests that for high-risk patients, a combination strategy may be more beneficial[4].

Implications for Clinical Practice

These findings challenge the previous recommendations from the European Society for Gastrointestinal Endoscopy (ESGE) to routinely give prophylactic rectal indomethacin to all patients undergoing ERCP, including those at average risk for PEP. The studies highlight the need for a more nuanced approach, considering the individual risk profile of each patient rather than a one-size-fits-all strategy[1].

Market Analysis

Market Size and Growth

The indomethacin market is expected to witness significant growth during the forecast period from 2023 to 2031. This growth is driven by several factors:

• Increasing Prevalence of Chronic Conditions: The rising prevalence of gout and arthritis, along with a growing focus on treating these and other chronic conditions, is driving the demand for indomethacin[3].
• Expanding Pharmaceutical Industry: The growth of the pharmaceutical industry in developing nations is creating new opportunities for the indomethacin market[3].

Market Segmentation

The indomethacin market is segmented based on several criteria:

• Type: Indomethacin is available in various forms, including tablets, capsules, suppositories, and others. Each form has its own market share and growth potential[3][5].
• Age Group: The market is segmented into children and adults, with the adult segment being the largest due to the higher prevalence of chronic inflammatory conditions in this age group[3][5].
• Distribution Channel: The market is further segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Online pharmacies are increasingly popular due to their convenience and accessibility[3][5].

Regional Framework

The global indomethacin market is analyzed across several regions, including North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region has its own market dynamics, driven by local healthcare policies, economic conditions, and patient demographics[3].

Competitive Landscape

The indomethacin market is highly competitive, with several major players dominating the market. Key companies include Merck, Xinhua Pharma, Hotai Pharma, and others. These companies compete based on the quality of their products, services, and advanced characteristics. The market is also influenced by factors such as strong competition, technological advances, and the potential for technological obsolescence[2][5].

Market Projections

Growth Rate and Market Size

The global indomethacin market is projected to grow at a significant Compound Annual Growth Rate (CAGR) during the forecast period. For instance, the market is expected to grow at a CAGR of around 7.70% from 2021 to 2027[5].

• Historical Data and Forecast: Market reports provide historical data from 2021-2022 and forecast data from 2024-2031, helping stakeholders understand the market's past performance and future potential[3].
• Market Size: The market size is expected to increase substantially, with estimates suggesting it will reach several million dollars by 2031[3].

Drivers and Restraints

The growth of the indomethacin market is driven by several factors:

• Increasing Demand: The rising demand for effective treatments for chronic inflammatory conditions is a major driver.
• Expanding Pharmaceutical Industry: Growth in the pharmaceutical sector, especially in developing countries, is another significant factor.
• Technological Advancements: Continuous innovations in drug delivery systems and formulations are also driving the market[3].

However, there are also restraints to consider:

• Side Effects and Safety Concerns: Indomethacin, like other NSAIDs, can have significant side effects, which may limit its use in some patients.
• Regulatory Challenges: Strict regulatory environments in some regions can affect the market's growth[3].

Key Takeaways

• Clinical Efficacy: Recent clinical trials suggest that indomethacin may not be universally effective in preventing PEP, and its use should be tailored to individual patient risk profiles.
• Market Growth: The indomethacin market is expected to grow significantly due to increasing demand for treatments of chronic inflammatory conditions and the expansion of the pharmaceutical industry.
• Segmentation: The market is segmented by type, age group, and distribution channel, each with its own growth potential.
• Regional Dynamics: The market varies significantly across different regions, influenced by local healthcare policies and patient demographics.

FAQs

What is indomethacin used for?

Indomethacin is used to relieve pain and swelling in patients suffering from arthritis, bursitis, gout, tendonitis, and other inflammatory conditions.

Is indomethacin effective in preventing post-ERCP pancreatitis?

Recent clinical trials suggest that indomethacin may not be effective in preventing post-ERCP pancreatitis in all patients, especially those at average risk. For high-risk patients, a combination of indomethacin and a prophylactic pancreatic stent may be more effective.

What are the key drivers of the indomethacin market?

The key drivers include the increasing prevalence of chronic inflammatory conditions, growing focus on treating these conditions, and the expansion of the pharmaceutical industry in developing nations.

Who are the major players in the indomethacin market?

Major players include Merck, Xinhua Pharma, Hotai Pharma, and others.

What is the projected growth rate of the indomethacin market?

The market is projected to grow at a CAGR of around 7.70% from 2021 to 2027.

Sources

1. Penn State Health: "Routine Prophylactic Indomethacin for All ERCP Patients Called Into Question"
2. PharmiWeb: "Indomethacin Market Projections, SWOT Analysis, Risk Analysis And Forecast By 2020-2025"
3. The Insight Partners: "Indomethacin Market Insights and Growth by 2031"
4. PubMed: "Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial."
5. OpenPR: "Indomethacin Market is projected to expand and has remarkable scope during the forecast period 2020-2025"