CLINICAL TRIALS PROFILE FOR CHILDREN'S IBUPROFEN

505(b)(2) Clinical Trials for Children's Ibuprofen

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00267293 ↗	Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever	Completed	Children Youth and Family Consortium	Phase 4	2006-01-01	Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
OTC	NCT00267293 ↗	Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever	Completed	Penn State University	Phase 4	2006-01-01	Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
New Indication	NCT01478022 ↗	To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20	Completed	Parent Project, Italy	Phase 1	2011-10-01	This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU 200 and IBU and ISO combinations (200 +20) given in single dose. This study is being conducted to support the submission for new indication in treatment of the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for Duchenne muscular dystrophy.
OTC	NCT03509675 ↗	Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions.	Completed	University of Washington	Phase 2/Phase 3	2018-04-29	Oral lichen planus (OLP) is a common chronic autoimmune disease associated with cell-mediated immunological dysfunction. Symptomatic OLP is painful and complete healing is rare. Current treatments for lichen planus and lichenoid mucositis are usually directed towards reducing the symptoms. This double-blinded cross-over placebo-controlled clinical trial is designed to measure the effectiveness of a topical NSAID (Ibuprofen suspension - 100mg/5ml) compared with a placebo in reducing pain associated with Oral Lichen Planus and Oral Lichenoid Lesions. Exclusion criteria include: - The occurrence of dysplasia in the histopathological specimen - Known or suspected sensitivity to NSAID medication - History of asthma - History of gastrointestinal ulceration - History of bleeding disorders - Pregnancy Outcome measures are self-reported pain scores at day 0, day 4 and day 7 of use of the placebo or active suspension, using a horizontal 100 mm, visual analog scale (VAS). If subjects were already on active treatment at the time of enrollment, they will be asked to discontinue for 7 days for a washout period before starting the research study. cord their spontaneous pain level on a 0-10 VAS. Participants will be contacted initially after the first day of the intervention to discuss any concerns or questions. Every week, reminder phone calls will be made to the subjects to fill out the forms from the investigator and to check for any side effects from the intervention. Both the patient and the investigator will be blinded for the content of each bottle.
OTC	NCT05640674 ↗	Post-operative Pain Management in Children With Supracondylar Humerus Fractures	Not yet recruiting	Baylor College of Medicine	Phase 4	2022-12-01	There are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: opioids vs over the counter pain medications. The purpose of this study is to determine if ibuprofen and acetaminophen can provide similar or better pain relief compared to ibuprofen and hydrocodone/acetaminophen (also known as Hycet) for this population of children after they have been discharged. If over the counter medications can provide adequate pain relief, then fewer opioid prescriptions would be necessary. This reduces early opioid exposure and decreases unnecessary opioids in circulation.

All Clinical Trials for Children's Ibuprofen

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00115336 ↗	Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease	Terminated	National Heart, Lung, and Blood Institute (NHLBI)	Phase 4	2005-01-01	The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).
NCT00115336 ↗	Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease	Terminated	University of Texas Southwestern Medical Center	Phase 4	2005-01-01	The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).
NCT00115336 ↗	Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease	Terminated	Children's Hospital Medical Center, Cincinnati	Phase 4	2005-01-01	The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).
NCT00121563 ↗	Evaluation of a TNF-Alpha Modulator for Clinical and Molecular Indicators of Analgesic Effect	Completed	National Institute of Nursing Research (NINR)	Phase 2	2005-07-01	This study will evaluate the role of thalidomide, a tumor necrosis factor (TNF)-alpha modulator, on severe inflammation and relief of pain following extraction of wisdom teeth. TNFs are substances that affect the pathways of pain. This study involves an experimental group in which patients will be given thalidomide or a placebo (an inactive substance); a negative control group receiving the medication diazepam or a placebo; and a positive control group receiving diazepam or ibuprofen. Patients who are males ages 16 to 35, who are not allergic to aspirin or other nonsteroidal anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics, and who in good health may be eligible for this study. Females are not eligible, owing to the risks that thalidomide presents to unborn children. To minimize the risk of fetal malformations, male patients who participate must use a condom during sexual intercourse for 4 weeks following the study and must not donate blood for 4 weeks. The medications used in the study will be given 1 hour before surgery. Then after the wisdom teeth are removed, a small piece of tubing will be placed into both sides of the patient's mouth where the teeth were removed. Every 20 minutes, for the next 6 hours, the researchers will collect inflammatory fluid from the tubing, to measure for changes in anti-inflammatory action. If they request pain relievers, patients will receive the medication ketorolac (Toradol), used for short-term treatment of moderately severe acute pain. Side effects of thalidomide include fatigue, dizziness, and rash. The use of ibuprofen and ketorolac may include the risk of gastrointestinal ulcers and bleeding. Diazepam can cause involuntary muscle movements and drowsiness, as well as dizziness lasting for up to 24 hours after it has been used as sedation. Patients will be instructed not to try to walk alone or to try to drive a vehicle during that period. Other risks related to participation in this study include those usually experienced with removal of wisdom teeth-that is, pain and swelling, bruising from insertion of the sedative into a vein (if needed), possible infection at the extraction site, prolonged bleeding, and numbness. Benefits from participating are having wisdom teeth removed at no cost as well as close monitoring before and after surgery. Results from the study may help people in the future by improving the management of pain following surgery.
NCT00167713 ↗	Treatment of Fever Due to Malaria With Ibuprofen	Completed	Albert Schweitzer Hospital	Phase 4	2003-04-01	Drugs to treat fever are widely used in children with fever. But there is a controversy about the benefit of reducing fever in children with malaria. Ibuprofen is often used to treat malarial fever. This study evaluates the capacity of ibuprofen to reduce fever in malaria. The effect of ibuprofen on fever compared to only mechanical measures is investigated in children with malaria.
NCT00240812 ↗	A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 2	1969-12-31	The purpose of the study is to determine if ibuprofen in combination with pseudoephedrine HCl in the treatment of nightime bedwetting in children is more effective than each drug alone and if the individual drugs are more effective than placebo.
NCT00267293 ↗	Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever	Completed	Children Youth and Family Consortium	Phase 4	2006-01-01	Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.

Clinical Trial Conditions for Children's Ibuprofen

Condition Name

Condition Name for Children's Ibuprofen
Intervention	Trials
Fever	10
Pain	8
Pain, Postoperative	6
Tonsillectomy	4

Condition MeSH

Condition MeSH for Children's Ibuprofen
Intervention	Trials
Pain, Postoperative	18
Fever	11
Fractures, Bone	9
Acute Pain	5

Clinical Trial Locations for Children's Ibuprofen

Trials by Country

Trials by Country for Children's Ibuprofen
Location	Trials
United States	58
Canada	20
Egypt	6
Israel	5
Italy	3

Trials by US State

Trials by US State for Children's Ibuprofen
Location	Trials
Texas	7
Washington	5
Missouri	5
California	4
Virginia	3

Clinical Trial Progress for Children's Ibuprofen

Clinical Trial Phase

Clinical Trial Phase for Children's Ibuprofen
Clinical Trial Phase	Trials
Phase 4	28
Phase 3	12
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Children's Ibuprofen
Clinical Trial Phase	Trials
Completed	52
Recruiting	17
Unknown status	13

Clinical Trial Sponsors for Children's Ibuprofen

Sponsor Name

Sponsor Name for Children's Ibuprofen
Sponsor	Trials
Lawson Health Research Institute	4
St. Justine's Hospital	4
Assaf-Harofeh Medical Center	3

Sponsor Type

Sponsor Type for Children's Ibuprofen
Sponsor	Trials
Other	121
U.S. Fed	14
Industry	12

Children's Ibuprofen: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

Children's ibuprofen is a widely used non-steroidal anti-inflammatory drug (NSAID) for managing pain, fever, and inflammation in pediatric populations. This article delves into the latest clinical trials, market analysis, and future projections for children's ibuprofen.

Clinical Trials Update

Efficacy and Safety in Postoperative Pain

A recent Cochrane review assessed the efficacy and safety of ibuprofen for acute postoperative pain management in children. The review included 43 randomized controlled trials (RCTs) involving 4265 children. Key findings indicate that ibuprofen probably reduces child-reported pain intensity less than two hours post-intervention compared to placebo, with moderate-certainty evidence. Additionally, ibuprofen may reduce pain intensity two hours to 24 hours post-intervention, although the evidence is of low certainty[1].

Comparison with Other Medications

When compared to paracetamol, ibuprofen likely reduces child-reported pain intensity less than two hours post-intervention and may slightly reduce pain intensity two hours to 24 hours post-intervention. There was little to no difference in adverse events between ibuprofen and paracetamol. In a comparison with morphine, ibuprofen likely results in a reduction in adverse events, highlighting its safer profile[1].

Aggressive Antipyretic Therapy

A randomized clinical trial conducted in Zambia and Malawi compared aggressive antipyretic therapy using scheduled acetaminophen and ibuprofen versus usual care with acetaminophen alone for children with central nervous system (CNS) malaria. The aggressive antipyretic group had a lower maximum temperature and lower odds of experiencing multiple or prolonged seizures, indicating the benefits of combined therapy in managing fever and preventing neurological complications[4].

Market Analysis

Global Market Size and Growth

The global ibuprofen market, including children's formulations, is expected to grow significantly. By 2033, the market size is projected to reach approximately USD 205.6 million, growing at a Compound Annual Growth Rate (CAGR) of 7.8% from 2024 to 2033. This growth is driven by increasing chronic pain conditions and the efficacy of ibuprofen in managing pain and inflammation[5].

Regional Market Analysis

North America currently dominates the ibuprofen market, capturing over 41.6% of the global share. This is attributed to high healthcare expenditure, a well-established pharmaceutical industry, and a robust distribution network. The Asia Pacific region, particularly India and China, is also expected to contribute significantly due to low manufacturing costs and increasing health expenditure[5].

Product Segmentation

The market is segmented by type, with tablets holding the dominant position at over 41.6% market share in 2023, followed by capsules and syrups. The ease of consumption and widespread availability of tablets contribute to their popularity. Syrups, particularly useful for pediatric and geriatric populations, also play a significant role[5].

Market Projections

Forecasted Growth

The ibuprofen API market is expected to grow from USD 727.09 million in 2025 to USD 936.89 million by 2037, at a CAGR of more than 2.1%. This growth is driven by the increasing prevalence of influenza and other infectious diseases, for which ibuprofen is often used in combination with acetaminophen to relieve symptoms[2].

Key Drivers

The demand for ibuprofen is driven by several factors, including the growing aging population, increasing chronic pain conditions, and the efficacy of ibuprofen in managing pain and inflammation. Additionally, the rise in health expenditure and the growing awareness about pediatric medicine are expected to boost the market[5].

Regulatory Challenges

Despite the positive growth projections, the market faces regulatory challenges. Stringent regulatory frameworks and approval processes can pose barriers to the introduction of new ibuprofen products, potentially limiting market growth[5].

Pediatric Clinical Trials Market

Growth and Trends

The global pediatric clinical trials market is projected to reach USD 25.13 billion by 2032, growing at a CAGR of 6.2% from 2024 to 2032. This growth is driven by unmet medical needs in the pediatric population, a shift towards contract research organizations (CROs), and an increasing burden of pediatric diseases such as diabetes[3].

Phase Segmentation

Phase II trials currently hold the largest market share, contributing over 35% of global revenue. These trials are crucial for examining the safety and effectiveness of interventions in children. Phase IV post-marketing trials, though less common, are necessary for ensuring the long-term safety and efficacy of medications in pediatric populations[3].

Key Takeaways

• Clinical Efficacy: Ibuprofen is effective in reducing postoperative pain in children, with moderate to low certainty evidence depending on the time frame.
• Market Growth: The global ibuprofen market is expected to grow significantly, driven by chronic pain conditions and the efficacy of ibuprofen.
• Regional Dominance: North America currently leads the market, while the Asia Pacific region is expected to grow due to low manufacturing costs and increasing health expenditure.
• Product Segmentation: Tablets dominate the market, followed by capsules and syrups, each catering to different consumer preferences.
• Regulatory Challenges: Stringent regulatory frameworks can limit the introduction of new products.

FAQs

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

The ibuprofen API market size was over USD 715.08 million in 2024 and is estimated at USD 727.09 million in 2025[2].

How effective is ibuprofen in managing postoperative pain in children?

Ibuprofen probably reduces child-reported pain intensity less than two hours post-intervention compared to placebo, with moderate-certainty evidence. It may also reduce pain intensity two hours to 24 hours post-intervention, although the evidence is of low certainty[1].

What are the key drivers of the ibuprofen market growth?

The key drivers include the growing aging population, increasing chronic pain conditions, and the efficacy of ibuprofen in managing pain and inflammation. Additionally, the rise in health expenditure and growing awareness about pediatric medicine contribute to market growth[5].

Which region is expected to dominate the ibuprofen market in the future?

North America currently dominates the market, but the Asia Pacific region, particularly India and China, is expected to grow significantly due to low manufacturing costs and increasing health expenditure[5].

What are the regulatory challenges facing the ibuprofen market?

Stringent regulatory frameworks and approval processes can pose barriers to the introduction of new ibuprofen products, potentially limiting market growth[5].

Sources

1. Ibuprofen for acute postoperative pain in children - PubMed
2. Ibuprofen API Market Size & Share, Growth Trends 2037 - Research Nester
3. Pediatric Clinical Trials Market Size, Share & Trends By 2032 - Straits Research
4. Acetaminophen and Ibuprofen in Pediatric Central Nervous System ... - PubMed
5. Ibuprofen Market Size, Share, Growth | CAGR Of 7.8% - Market.US