CLINICAL TRIALS PROFILE FOR IBUPROFEN SODIUM

All Clinical Trials for Ibuprofen Sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00122278 ↗	Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines	Completed	Montefiore Medical Center	Phase 3	2005-07-01	Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.
NCT00261586 ↗	A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 4	1969-12-31	The purpose of this study is to compare several analgesics given in approved daily doses in combination with a daily cardioprotective dose of aspirin (81 mg), to study their bleeding properties and their effects on the stomach in healthy volunteers.
NCT00264381 ↗	Management of Superficial Thrombophlebitis	Completed	Pfizer	Phase 4	2002-10-01	The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium) subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three times daily for 7 days for the treatment of superficial thrombophlebitis (STP).
NCT00264381 ↗	Management of Superficial Thrombophlebitis	Completed	University of Oklahoma	Phase 4	2002-10-01	The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium) subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three times daily for 7 days for the treatment of superficial thrombophlebitis (STP).
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.
NCT00601458 ↗	Bunionectomy Study (0000-063)	Completed	Merck Sharp & Dohme Corp.	Phase 1	2007-07-01	We are interested in whether bunionectomy can be used as a model to study the treatment of acute pain. It has been used to study the effect of Non-Steroidal Anti-inflammatory (NSAIDS) medications (such as ibuprofen) and other pain relieving drugs. We are interested to know if this model is useful to study other drugs for the treatment of acute pain. The other drugs being tested in this study are pregabalin and naproxen sodium. These drugs are approved for use by the Food and Drug Administration (FDA). This study is designed to test whether these two drugs are effective in treating pain after a bunionectomy.

Clinical Trial Conditions for Ibuprofen Sodium

Condition Name

Condition Name for Ibuprofen Sodium
Intervention	Trials
Pain, Postoperative	2
Acute Pain	2
Carpal Tunnel Syndrome	2
Healthy	2

Condition MeSH

Condition MeSH for Ibuprofen Sodium
Intervention	Trials
Pain, Postoperative	5
Migraine Disorders	4
Ductus Arteriosus, Patent	2
Headache	2

Clinical Trial Locations for Ibuprofen Sodium

Trials by Country

Trials by Country for Ibuprofen Sodium
Location	Trials
United States	21
Canada	2
France	2
Brazil	2
Jordan	1

Trials by US State

Trials by US State for Ibuprofen Sodium
Location	Trials
California	4
Utah	3
Pennsylvania	3
Illinois	2
Oklahoma	2

Clinical Trial Progress for Ibuprofen Sodium

Clinical Trial Phase

Clinical Trial Phase for Ibuprofen Sodium
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	6
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Ibuprofen Sodium
Clinical Trial Phase	Trials
Completed	21
Recruiting	5
Unknown status	4

Clinical Trial Sponsors for Ibuprofen Sodium

Sponsor Name

Sponsor Name for Ibuprofen Sodium
Sponsor	Trials
Pfizer	3
Cairo University	3
Bayer	2

Sponsor Type

Sponsor Type for Ibuprofen Sodium
Sponsor	Trials
Other	46
Industry	14
NIH	2

Ibuprofen Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Ibuprofen sodium, a widely used nonsteroidal anti-inflammatory drug (NSAID), has been a cornerstone in the management of pain, inflammation, and fever. This article delves into recent clinical trials, market analysis, and future projections for ibuprofen sodium.

Clinical Trials: Ibuprofen in Preterm Infants

Patent Ductus Arteriosus (PDA) Treatment

A significant clinical trial published in JAMA Pediatrics investigated the noninferiority of nonintervention versus oral ibuprofen in treating hemodynamically significant PDA in very preterm infants. The study, conducted between 2014 and 2019, involved 146 infants born at 23-30 weeks of gestation. The results showed that nonintervention was noninferior to ibuprofen treatment in closing PDA and reducing the incidence of bronchopulmonary dysplasia (BPD) or death[1].

Another trial, the SMART-PDA Trial, aims to determine the benefits of early ibuprofen treatment for PDA in extremely preterm infants. This study compares early treatment with ibuprofen to no early treatment, monitoring for potential side effects such as harm to the gut and kidneys[4].

Clinical Trials: Postoperative Pain Management

Intravenous Ibuprofen

A phase III clinical trial published in PLOS ONE evaluated the efficacy and safety of intravenous (IV) ibuprofen for managing postoperative pain in adult patients undergoing abdominal or orthopedic surgery. The study found that IV ibuprofen significantly reduced total morphine use during the first 24 hours post-surgery compared to placebo, highlighting its potential in multimodal analgesic therapy[3].

Market Analysis

Global Ibuprofen API Market

The global ibuprofen active pharmaceutical ingredient (API) market is projected to grow significantly. In 2025, the market size is estimated at USD 727.09 million and is expected to cross USD 936.89 million by 2037, growing at a CAGR of more than 2.1% during the forecast period. This growth is driven by the increasing prevalence of influenza and COVID-19, which require antipyretic and analgesic treatments[2].

Application Segments

The arthritis segment is expected to dominate the ibuprofen API market, accounting for about 60% of the market share during the forecast period. This is due to the growing prevalence of arthritis, which affects millions globally and necessitates the use of NSAIDs like ibuprofen for pain management[2].

End-User Segments

Pharmaceutical and biopharmaceutical companies are expected to hold a significant share of the global ibuprofen API market, driven by increased investment and development in these sectors. The Asia Pacific region, particularly India and China, is anticipated to generate the highest share due to low manufacturing costs and rising health expenditure[2].

Market Projections

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Market

The global NSAIDs market, which includes ibuprofen, was valued at USD 19,551.54 million in 2021 and is projected to reach USD 31.45 billion by 2030, growing at a CAGR of 5.42%. The topical segment of NSAIDs is expected to experience the fastest growth rate, driven by the high demand for topical preparations[5].

Regional Growth

The Asia Pacific region is expected to continue its dominance in the ibuprofen API market due to favorable manufacturing conditions and increasing healthcare expenditure. The region's healthcare benefit costs have been rising, with an anticipated increase to approximately 11% in 2023, further boosting the market[2].

Key Takeaways

• Clinical Trials: Recent trials indicate that ibuprofen may not be superior to nonintervention in treating PDA in preterm infants, but it remains effective in postoperative pain management.
• Market Growth: The global ibuprofen API market is expected to grow significantly, driven by the increasing prevalence of diseases like influenza and arthritis.
• Application and End-User Segments: The arthritis segment and pharmaceutical/biopharmaceutical companies are key drivers of the ibuprofen API market.
• Regional Projections: The Asia Pacific region is anticipated to lead the market growth due to low manufacturing costs and rising healthcare expenditure.

FAQs

What is the current market size of the ibuprofen API market?

The global ibuprofen API market size is estimated at USD 727.09 million in 2025[2].

What are the primary drivers of the ibuprofen API market growth?

The primary drivers include the increasing prevalence of influenza, COVID-19, and arthritis, as well as the growing demand for antipyretic and analgesic treatments[2].

Which segment is expected to dominate the ibuprofen API market?

The arthritis segment is expected to dominate the market, accounting for about 60% of the market share during the forecast period[2].

What is the projected growth rate of the global NSAIDs market?

The global NSAIDs market is projected to grow at a CAGR of 5.42% from 2022 to 2030[5].

Which region is expected to lead the growth in the ibuprofen API market?

The Asia Pacific region, particularly India and China, is expected to lead the growth due to low manufacturing costs and rising health expenditure[2].

Sources

1. Effect of Nonintervention vs Oral Ibuprofen in Patent Ductus Arteriosus in Very Preterm Infants. JAMA Pediatrics, 2020.
2. Ibuprofen API Market Size & Share, Growth Trends 2037. Research Nester.
3. Intravenous Ibuprofen for Treatment of Post-Operative Pain. PLOS ONE.
4. Ibuprofen for Patent Ductus Arteriosus (SMART-PDA Trial). WithPower.
5. Non-steroidal Anti-inflammatory Drugs Market Size USD 31.45 Billion by 2030. BioSpace.

Last updated: 2025-01-04