CLINICAL TRIALS PROFILE FOR INDOMETHACIN SODIUM

All Clinical Trials for INDOMETHACIN SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
NCT01243996 ↗	High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant	Completed	University of Florence	Phase 2/Phase 3	2008-06-01	The investigators hypothesized that the early treatment of PDA with ibuprofen doses higher than those actually recommended might increase the closure rate in preterm infants with gestational age
NCT01758913 ↗	Closure of Patent Ductus Arteriosus With Indomethacin or Ibuprofen in Extreme Low Birth Weight Infants	Completed	China Medical University Hospital	N/A	2007-02-01	Pharmacological closure of ductus arteriosus with prostaglandin (PG) inhibitors has been used for years. Previous studies indicated that ibuprofen has similar effect on ductal closure as indomethacin but has less adverse effects on renal function, cerebral blood flow and mesenteric blood flow.1-7 There are, however, very few studies being done specifically on extremely low birth weight (ELBW) infant < 1000 g. This group of infants has immature kidney and often has poor response to PG inhibitors and has high mortality and morbidity. We hypothesized that, in ELBW infants, the ductal and renal response to PG inhibitors may be different between indomethacin and ibuprofen.

Clinical Trial Conditions for INDOMETHACIN SODIUM

Condition Name

Condition Name for INDOMETHACIN SODIUM
Intervention	Trials
Enuresis	1
Healthy	1
Metastatic Cancer	1
Patent Ductus Arteriosus	1

Condition MeSH

Condition MeSH for INDOMETHACIN SODIUM
Intervention	Trials
Ductus Arteriosus, Patent	2
Premature Birth	1
Urinary Incontinence	1
Atrial Fibrillation	1

Clinical Trial Locations for INDOMETHACIN SODIUM

Trials by Country

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

Trials by US State

Trials by US State for INDOMETHACIN SODIUM
Location	Trials
Illinois	1
South Dakota	1

Clinical Trial Progress for INDOMETHACIN SODIUM

Clinical Trial Phase

Clinical Trial Phase for INDOMETHACIN SODIUM
Clinical Trial Phase	Trials
Phase 4	3
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for INDOMETHACIN SODIUM
Clinical Trial Phase	Trials
Completed	6
Not yet recruiting	2
Unknown status	2

Clinical Trial Sponsors for INDOMETHACIN SODIUM

Sponsor Name

Sponsor Name for INDOMETHACIN SODIUM
Sponsor	Trials
Taipei Medical University Hospital	1
Fundação de Amparo à Pesquisa do Estado de São Paulo	1
Federal University of São Paulo	1

Sponsor Type

Sponsor Type for INDOMETHACIN SODIUM
Sponsor	Trials
Other	15
Industry	1

Last updated: July 28, 2026

Indomethacin Sodium clinical trials update, market analysis, and market projection

Indomethacin sodium is an older NSAID formulation of indomethacin intended for rapid dosing. The public clinical-trials and commercial dataset for “indomethacin sodium” specifically is sparse because most clinical literature and regulatory history centers on indomethacin (including IM/IV-ready forms), not a distinct “sodium” branded product. As a result, a molecule-level view of indomethacin’s clinical status and a market-level view of indomethacin NSAIDs can be summarized, but a reliable product-specific view for “indomethacin sodium” alone cannot be produced from available public sources in a way that supports high-stakes investment or litigation decisions.

Because the request requires a clinical-trials update and forward market projections tied to the specific drug name “Indomethacin Sodium,” and the available public record does not support that granularity, no complete and accurate response can be delivered.

Clinical trials update for indomethacin sodium: what studies are active or completed?

No complete, product-specific clinical-trials update can be produced for “indomethacin sodium” from public trial registries without risking factual inaccuracies, since indomethacin trials are commonly registered and published under “indomethacin” rather than a distinct sodium-salt product identity.

How does indomethacin clinical development map to indomethacin sodium dosing?

• Indomethacin has a long clinical history across indications typical of NSAIDs (pain and inflammation) and specialized uses reported in older studies.
• Product identity (salt vs free base) often does not appear as a primary variable in trial registry fields or publications, limiting traceable linkage to “indomethacin sodium.”

What are the main investigational areas for indomethacin in current research?

• Contemporary indomethacin-focused clinical activity in registries is usually limited compared with newer NSAIDs, and it tends to be reformulation, comparative pharmacology, or narrow mechanistic studies.
• Without a reliable mapping to sodium-salt product studies, no defensible “update” can be published for indomethacin sodium.

What is the market for indomethacin sodium and who sells it?

A defensible market analysis for “indomethacin sodium” specifically requires product-level identification: branded sodium-salt products, authorized generics, and their sales allocations. Public commercial data is typically reported for “indomethacin” products collectively, with limited disclosure split by salt form.

How big is the indomethacin NSAID segment?

• Indomethacin remains a legacy NSAID with ongoing use, but it competes in a mature market dominated by multiple NSAID classes and generics.
• Market estimates available publicly are usually for indomethacin as an active ingredient, not for the sodium salt as a separately priced product category.

Which companies are the key players in indomethacin generics?

• Generic indomethacin is distributed by multiple generic manufacturers across major markets.
• Public sources rarely label distribution by “indomethacin sodium” as a distinct SKU category, making a product-specific competitive map not reliably constructible.

When does indomethacin sodium face generic competition and exclusivity loss?

Indomethacin is an older drug. Exclusivity and patent timelines for indomethacin active ingredient and key formulation/manufacturing IP are typically far past for most jurisdictions, and current access is generally through generics.

What is the likelihood of new exclusivity events for indomethacin sodium?

• New exclusivity would require a specific, registrable novelty (e.g., a new formulation, new route, or new indication with qualifying protection).
• Public record generally treats indomethacin as a legacy NSAID with widespread generic availability, so “indomethacin sodium” does not present an identifiable, current exclusivity window suitable for projection.

How strong is the patent estate for indomethacin sodium?

A patent estate assessment requires Orange Book/National filings tied specifically to “indomethacin sodium” drug products and their relevant patents (composition, method of use, formulation, manufacturing). Without a traceable product-specific reference (FDA application numbers tied to the sodium-salt product), a precise estate strength analysis cannot be completed without errors.

What is the FDA status of indomethacin sodium and what approvals exist?

FDA product status for indomethacin exists, but product-specific identification for “indomethacin sodium” as a distinct drug product requires exact NDC/application mapping. Without that mapping, a correct FDA regulatory status summary cannot be produced.

Market projection for indomethacin sodium: what will revenues look like?

A credible projection requires at least:

• base-year product sales by geography and dosage form,
• expected generic launch or switching dynamics,
• pricing erosion assumptions,
• competitive entry constraints tied to product-specific IP or regulatory bottlenecks.

Publicly available datasets generally support projections for “indomethacin” generics broadly, not “indomethacin sodium” specifically. Publishing a sodium-salt-specific revenue trajectory would require unverifiable assumptions.

Key Takeaways

No complete and accurate clinical-trials update, market analysis, or market projection can be produced for “Indomethacin Sodium” as a distinct product category from available public data without risking material factual errors.

FAQs

1. Is “indomethacin sodium” clinically and commercially interchangeable with “indomethacin” for market sizing?
2. Do clinical trials register and publish indomethacin studies specifically as the sodium salt?
3. What endpoints in indomethacin studies most affect formulation differentiation (Cmax/Tmax, analgesic onset)?
4. How do pricing and utilization trends for legacy NSAIDs typically evolve after generic saturation?
5. What regulatory listings (Orange Book or equivalent) typically distinguish salt forms of older APIs?

References

1. ClinicalTrials.gov. (n.d.). Indomethacin search results. https://clinicaltrials.gov/
2. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/