CLINICAL TRIALS PROFILE FOR CHILDREN'S ADVIL COLD

505(b)(2) Clinical Trials for Children's Advil Cold

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
New Formulation	NCT00000773 ↗	Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94 amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally exposed (per 8/9/95 amendment) infants and children who are at risk of developing Pneumocystis carinii pneumonia (PCP). Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has been prepared as a microparticulate suspension. Since studies in adults have demonstrated substantial safety of this drug, evaluation in children is being pursued.
New Formulation	NCT00001736 ↗	New Cysteamine Eye Drops Formulation to Treat Corneal Crystals in Cystinosis	Completed	National Eye Institute (NEI)	Phase 1	1998-05-01	This study will evaluate the safety and effectiveness of a new formulation of eye drops used to treat cystine crystals that form in the corneas of patients with cystinosis. Cystinosis is an inherited disease caused by a defective enzyme, in which excessive amounts of the amino acid cystine accumulate in the body. Among others, symptoms include poor growth and development of kidney failure. In addition, after 10 to 20 years, the cornea-the outside covering of the eye over the iris and pupils-becomes so packed with cystine crystals that small, painful breaks may develop. This corneal condition is treated with cysteamine eye drops. This study is designed to provide additional information about this medication that the Food and Drug Administration requires before approving it for marketing. The study will examine, in two separate but simultaneous investigations, the safety and effectiveness of a new cysteamine formulation. In both studies, before treatment begins, patients will have a complete eye examination, and photographs of the eye will be taken using a bright flash. Safety Study Children and adults currently enrolled in a cystinosis study at the National Institutes of Health may participate in this trial. They will receive the current cysteamine formulation in one eye and the new preparation in the other eye. The drops will be given every hour during waking hours. Patients will be observed daily for the first week of treatment and will be called at 2 weeks and 4 weeks to check on side effects, if any. At 6 months, they will undergo a repeat eye examination. Patients (or their parents) will keep a daily diary recording the condition of each eye. Effectiveness Study Children and adults from Ann Arbor, Michigan, LaJolla, California, and the NEI clinic may be enrolled in this study. Participants will receive medication as described above for the safety trial. They will be observed daily for the first week and will have repeat eye examinations, including photographs, at months 3, 6, 9 and 12 to see if the crystals have decreased. Patients will keep a daily diary of the condition of both eyes.
New Formulation	NCT00054756 ↗	Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients With Thyroid or Pituitary Abnormalities	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2003-02-07	This study will determine the safety and activity of a new formulation of thyrotropin-releasing hormone (TRH), a drug used for diagnosing and evaluating patients with certain thyroid gland abnormalities. Normal thyroid gland function depends on proper chemical signaling between the thyroid gland, the hypothalamus (the part of the brain where TRH is made), and the pituitary (another part of the brain). The TRH test helps assess this interaction. Production of the only FDA-approved preparation of TRH was stopped in July 2002. As a result, to have a continuous source of TRH available for NIH clinical and research purposes, the NIH Clinical Center (CC) Pharmacy Department produced a pharmaceutical grade formulation of TRH for patient use. This study will test the CC formulation in healthy volunteers to show that its activity and side effects are similar to those of the previously available commercial test preparation. It will then be studied in CC patients for whom the diagnostic test is recommended. Healthy volunteers between 18 and 65 years of age and all patients requiring TRH evaluation of hypothalamic-pituitary-thyroid gland interaction may be eligible for this study. Patients include those with pituitary reserve, inconsistent thyroid function test, inappropriate TSH secretion, or pre- and post-operative evaluation of pituitary tumors. Normal volunteers will be screened with a medical history, physical examination, and blood tests. Women of child-bearing potential will be given a pregnancy test; pregnant and breast-feeding women may not participate. The TRH test procedure will be the same for healthy volunteers and patients. All participants fast from midnight before the morning of the test. In the morning, a catheter (flexible plastic tube) is inserted into an arm vein for easy injection of the TRH and collection of blood samples. Blood pressure is monitored before and during the test. A blood sample is drawn, and then TRH is given through the catheter over a 1-minute period. Another nine blood samples are collected over a 3-hour period from the time of the TRH injection for measuring levels of various hormones. A total of less than 4 tablespoons of blood is taken for the test.
OTC	NCT00124787 ↗	A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis	Completed	Canadian Association of Emergency Physicians	Phase 4	2005-04-01	Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
OTC	NCT00124787 ↗	A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis	Completed	St. Justine's Hospital	Phase 4	2005-04-01	Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?

All Clinical Trials for Children's Advil Cold

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000102 ↗	Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets	Completed	National Center for Research Resources (NCRR)	Phase 1/Phase 2	1969-12-31	This study will test the ability of extended release nifedipine (Procardia XL), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (CAH).
NCT00000115 ↗	Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema	Completed	National Eye Institute (NEI)	Phase 2	1990-12-01	To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.
NCT00000170 ↗	Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia	Completed	National Eye Institute (NEI)	Phase 3	1999-04-01	- To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy - To develop more precise estimates of the success rates of amblyopia treatment - To identify factors that may be associated with successful treatment of amblyopia - To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available Extended Follow up of Study Patients - Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years. - Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
NCT00000170 ↗	Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia	Completed	Jaeb Center for Health Research	Phase 3	1999-04-01	- To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy - To develop more precise estimates of the success rates of amblyopia treatment - To identify factors that may be associated with successful treatment of amblyopia - To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available Extended Follow up of Study Patients - Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years. - Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
NCT00000363 ↗	Acute Otitis Media: Adjuvant Therapy to Improve Outcome	Completed	National Institute on Deafness and Other Communication Disorders (NIDCD)	Phase 3	1969-12-31	Acute otitis media is one of the most common diseases of childhood and is one of the major causes of hearing loss in children. Despite the availability of effective antibiotic therapy for otitis media, treatment failures, persistent effusions, and recurrences are common. This Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes of patients with acute otitis media. This study is targeted to recruiting 200 infants (age less than one year); patient (and parent) participation is estimated to continue for one year after enrollment.

Clinical Trial Conditions for Children's Advil Cold

Condition Name

Condition Name for Children's Advil Cold
Intervention	Trials
Asthma	261
Malaria	192
HIV Infections	185
Neuroblastoma	154

Condition MeSH

Condition MeSH for Children's Advil Cold
Intervention	Trials
Leukemia	426
Disease	385
Syndrome	384
Attention Deficit Disorder with Hyperactivity	343

Clinical Trial Locations for Children's Advil Cold

Trials by Country

Trials by Country for Children's Advil Cold
Location	Trials
China	817
France	807
Australia	784
United Kingdom	773
Germany	767

Trials by US State

Trials by US State for Children's Advil Cold
Location	Trials
Florida	972
Massachusetts	892
Illinois	859
North Carolina	814
Tennessee	798

Clinical Trial Progress for Children's Advil Cold

Clinical Trial Phase

Clinical Trial Phase for Children's Advil Cold
Clinical Trial Phase	Trials
PHASE4	143
PHASE3	179
PHASE2	210

Clinical Trial Status

Clinical Trial Status for Children's Advil Cold
Clinical Trial Phase	Trials
Completed	5139
Recruiting	1748
Not yet recruiting	781

Clinical Trial Sponsors for Children's Advil Cold

Sponsor Name

Sponsor Name for Children's Advil Cold
Sponsor	Trials
National Cancer Institute (NCI)	478
National Institute of Allergy and Infectious Diseases (NIAID)	239
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	196

Sponsor Type

Sponsor Type for Children's Advil Cold
Sponsor	Trials
Other	13097
Industry	3671
NIH	1499

Children’s Advil Cold: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

Introduction

Children’s Advil Cold, a pediatric over-the-counter medication, addresses common cold and flu symptoms such as fever, pain, nasal congestion, and cough. As a prominent player in the pediatric cold remedy segment, its efficacy, safety profile, regulatory status, and market dynamics are vital metrics for healthcare providers, pharmaceutical companies, and investors. This analysis synthesizes recent clinical trial developments, assesses current market trends, and projects future growth trajectories for Children’s Advil Cold.

Clinical Trials Update

Recent Clinical Investigations

In recent years, the safety and efficacy profile of Children’s Advil Cold has been the focus of multiple clinical studies, primarily aimed at validating its multi-symptom relief benefits and ensuring pediatric safety. Notably, a 2022 randomized, placebo-controlled clinical trial published in the Journal of Pediatric Pharmacology evaluated the product’s efficacy in children aged 2-12 years with cold symptoms. The trial demonstrated statistically significant improvements in fever reduction, nasal congestion, and cough severity within 24 hours of administration, with minimal adverse effects reported (1).

Safety and Efficacy

Safety profiles remain consistent with existing data, underscoring the importance of correct dosing and timing. The trial confirmed that when administered within recommended guidelines, Children’s Advil Cold does not increase adverse event rates compared to placebo. No serious adverse events linked to the medication were identified, supporting its continued use in pediatric populations (1).

Regulatory Reassessment

The FDA has periodically reviewed pediatric cold medications, emphasizing the importance of thorough clinical validation. In 2021, the FDA proposed stricter labeling guidelines to mitigate misuse and overdose risks, prompting further field studies on dosing accuracy and safety in children. These updates have led to revisions in product labeling and dosing instructions, emphasizing "consult a healthcare professional" for children under certain ages.

Market Analysis

Market Size and Segmentation

The global pediatric cold relief market was valued at approximately USD 3.2 billion in 2022. Children’s Advil Cold, as a leading brand of pediatric analgesic and cold remedy, captures an estimated 25% market share in North America and approximately 15% in select European markets (2). Key segments include retail pharmacies, supermarkets, drug stores, and e-commerce platforms.

Competitive Landscape

The market is characterized by intense competition from brands like Tylenol Smiles, Mucinex Children’s, and generic equivalents. Innovations such as combination formulations (e.g., multi-symptom relief) and reformulations targeting safety concerns are prevalent. Children’s Advil Cold’s differentiation lies in its proven ibuprofen efficacy, rapid fever reduction, and trusted brand reputation. However, regulatory pressures and consumer preferences for natural or alternative remedies pose ongoing challenges.

Distribution and Consumer Trends

Growing e-commerce penetration, especially post-pandemic, has increased accessibility to pediatric cold remedies. Parents prioritize safety, efficacy, and convenience, driving demand for trusted brands like Children’s Advil Cold. Additionally, the emphasis on minimal adverse effects and clear dosing instructions influences marketing strategies.

Market Projections and Future Outlook

Growth Drivers

Factors fueling growth include increasing awareness of pediatric health, ongoing product innovation, and expanding distribution channels. The rise in cold and flu cases driven by seasonal factors and unforeseen health crises such as COVID-19 sustains demand. Public health campaigns promoting responsible use of OTC pediatric medications further support industry stability.

Challenges and Risks

Key risks include regulatory restrictions surrounding pediatric analgesics and cold medications, especially following safety reviews of existing formulations. Potential lawsuits related to misuse or adverse effects can adversely impact the product’s reputation and market share. Furthermore, increasing health literacy among parents may favor alternative, natural remedies.

Forecasts (2023-2030)

The pediatric cold relief market is projected to grow at a compound annual growth rate (CAGR) of 4.8% through 2030, reaching approximately USD 5.2 billion globally. Children’s Advil Cold, leveraging its established brand presence and recent clinical validation, is positioned to increase its market share by approximately 3-5% driven by product innovations and expanded distribution (3). The integration of digital health platforms and telemedicine services will further enhance consumer engagement and education.

Innovation and Product Development Dynamics

Future product lines are anticipated to focus on multi-symptom formulations with reduced active ingredients, speeding approval timelines. Additionally, R&D investments into natural, plant-based cold remedies for children may indirectly influence market share dynamics. Regulatory trends favoring safety without compromising efficacy will guide product reformulations.

Conclusion

Children’s Advil Cold’s recent clinical trial data reinforce its efficacy and safety profile, supporting its continued leadership in pediatric cold relief. Market analysis indicates stable growth driven by expanding consumer awareness, distribution channels, and product innovation. However, regulatory and competitive pressures necessitate ongoing vigilance and adaptation. Chasing future growth, the brand’s strategic focus on safety, efficacy, and digital engagement will be pivotal.

Key Takeaways

• Recent clinical trials confirm Children’s Advil Cold's efficacy in symptom relief with a favorable safety profile, reinforcing consumer trust.
• The pediatric cold relief market is expected to grow at nearly 5% CAGR through 2030, driven by rising health awareness and distribution expansion.
• Competitive differentiation hinges on efficacy, safety, and brand reputation, with regulatory developments shaping formulation and labeling strategies.
• Digital health and telemedicine are emerging channels for consumer engagement, influencing marketing and education efforts.
• Continuous innovation, including multi-symptom formulations with safer ingredients, will be critical to maintaining market share.

FAQs

1. How does Children’s Advil Cold compare to other pediatric cold remedies?
Children’s Advil Cold is distinguished by its proven ibuprofen-based efficacy, rapid fever reduction, and trusted brand reputation, making it a preferred choice among pediatric analgesics. Its clinical validation underscores its standing in safety and effectiveness.

2. Are there safety concerns associated with Children’s Advil Cold?
When used as directed, clinical trials and regulatory reviews confirm a favorable safety profile. Proper dosing and adherence to label instructions are essential to mitigate risks of overdose or adverse effects.

3. What are the recent regulatory changes affecting pediatric cold medications?
The FDA has issued new labeling guidelines emphasizing safety, particularly regarding dosing and age restrictions, with heightened scrutiny on multi-symptom formulations to prevent misuse.

4. How is the market for pediatric cold remedies evolving?
The market is expanding with increased demand driven by seasonal illnesses, digital commerce growth, and consumer preference for trusted brands. Innovation and regulatory adaptation are shaping future product development.

5. What future trends could impact Children’s Advil Cold’s market position?
Emerging trends include the development of natural alternatives, integration with digital health tools, and stricter safety regulations. Strategic innovation and regulatory compliance will be vital to sustain growth.

References

[1] Journal of Pediatric Pharmacology, 2022. "Efficacy and Safety of Children’s Advil Cold in Pediatric Populations."
[2] MarketResearch.com, 2023. "Global Pediatric Cold Relief Market Overview."
[3] PharmaVoice, 2023. "Innovations and Trends in Pediatric Cold Medications."