CLINICAL TRIALS PROFILE FOR CHILDREN'S ADVIL ALLERGY SINUS

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

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?
OTC	NCT00127686 ↗	Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep	Completed	National Honey Board	Phase 1	2005-09-01	Cough is the most common reason for an acute care doctor's visit in the United States. Cough can affect sleep for both coughing children and their parents. The American Academy of Pediatrics does not endorse the use of dextromethorphan (DM), the most common over-the-counter (OTC) cough medication because of a lack of efficacy data and some potential for toxicity, particularly when taken in excess. In fact, DM has previously been shown to be no better than a placebo for cough in children. Therefore, alternative, therapeutic agents are needed. Honey anecdotally provides relief for symptoms due to upper respiratory tract infection (URI). This study seeks to use a survey to evaluate whether a single dose of honey and/or DM is better than no treatment at all for controlling nocturnal cough in children with URI and the effect of the treatments on sleep quality for coughing children and their parents. A single dose of honey or DM will be superior to no treatment for control of nocturnal cough due to upper URI as rated by both parents and children and will improve the sleep quality for those children and parents. Compared to DM, honey will be superior for controlling nocturnal cough due to upper URI (also based on child and parental report).

All Clinical Trials for Children's Advil Allergy Sinus

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.
NCT00000381 ↗	Fluoxetine for Anxious Children	Completed	National Institute of Mental Health (NIMH)	Phase 3	1997-06-01	The purpose of this study is to see if it is safe and effective to use fluoxetine to treat children and adolescents with Generalized Anxiety Disorder (GAD). Anxiety disorders are one of the most common psychiatric disorders in children and adolescents, and can cause disturbances in the child's school, social, and family lives. Having an anxiety disorder puts a child at risk for depression and drug abuse, and appears to continue into adulthood. There is very little information on anxiety medications for children. Children will be assigned randomly (like tossing a coin) to receive either fluoxetine or an inactive placebo for 12 weeks. Each child will be monitored for symptoms and side effects throughout the study. He/she will have blood tests at Weeks 4, 8, and 12 to measure drug levels in the blood. The study will last for 12 weeks. A child is eligible for this study if he/she: Is 8 to 17 years old and has anxiety disorder. A child will not be eligible for this study if he/she: Has current major depression, panic disorder, or obsessive-compulsive disorder, or abuses alcohol or drugs.

Clinical Trial Conditions for Children's Advil Allergy Sinus

Condition Name

Condition Name for Children's Advil Allergy Sinus
Intervention	Trials
Asthma	261
Malaria	193
HIV Infections	185
Neuroblastoma	155

Condition MeSH

Condition MeSH for Children's Advil Allergy Sinus
Intervention	Trials
Leukemia	426
Disease	385
Syndrome	384
Attention Deficit Disorder with Hyperactivity	344

Clinical Trial Locations for Children's Advil Allergy Sinus

Trials by Country

Trials by Country for Children's Advil Allergy Sinus
Location	Trials
China	835
France	812
Australia	792
United Kingdom	775
Germany	770

Trials by US State

Trials by US State for Children's Advil Allergy Sinus
Location	Trials
Florida	977
Massachusetts	899
Illinois	862
North Carolina	814
Tennessee	801

Clinical Trial Progress for Children's Advil Allergy Sinus

Clinical Trial Phase

Clinical Trial Phase for Children's Advil Allergy Sinus
Clinical Trial Phase	Trials
PHASE4	157
PHASE3	192
PHASE2	218

Clinical Trial Status

Clinical Trial Status for Children's Advil Allergy Sinus
Clinical Trial Phase	Trials
Completed	5144
Recruiting	1759
Not yet recruiting	781

Clinical Trial Sponsors for Children's Advil Allergy Sinus

Sponsor Name

Sponsor Name for Children's Advil Allergy Sinus
Sponsor	Trials
National Cancer Institute (NCI)	479
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 Allergy Sinus
Sponsor	Trials
Other	13170
Industry	3687
NIH	1500

Children's Advil Allergy Sinus Market Analysis and Financial Projection

Last updated: April 27, 2026

Clinical Trials Update, Market Analysis, and Projection for “Children’s Advil Allergy Sinus”

What is “Children’s Advil Allergy Sinus” and what’s driving its regulatory path?

“Children’s Advil Allergy Sinus” is a branded, over-the-counter (OTC) pediatric combination product marketed for allergy and sinus symptom relief. In the US, this product category generally sits under OTC drug monograph or approved NDAs/ANDAs depending on the exact active-ingredient set, dosage form, and labeling claims. Without the specific “Drug Facts” active-ingredient list and strengths, a definitive regulatory and clinical-trial mapping cannot be completed with high confidence.

No complete, source-verifiable clinical trial registry footprint can be tied uniquely to the product name string “Children’s Advil Allergy Sinus” because OTC branded products are often not studied as a single branded entity in clinical trials; they are evaluated through ingredient-level evidence, formulation bioequivalence for certain product types, and postmarketing safety surveillance.

Implication for clinical-trials updates: a reliable trial update requires the exact active ingredients and strengths (and the dosage form), because trial records track ingredients (and sometimes specific fixed-dose combinations), not brand names. With only the brand name, trial-level update and market projection would risk incorrect attribution.

Are there clinical trials for this product as a branded combination?

OTC pediatric combination products are most commonly assessed through:

• ingredient-level clinical evidence (e.g., antihistamines, decongestants, analgesics),
• formulation performance (bioavailability where relevant),
• safety surveillance rather than sponsor-run randomized efficacy trials under the exact product brand name.

A brand-name-only query typically returns either:

• trials for the underlying active ingredients (not the branded pediatric combination), or
• unrelated studies that mention “children’s” or “sinus” in the context of other products.

Result: a complete clinical-trials update cannot be produced accurately from the provided product description alone.

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Market Analysis: How the OTC “allergy and sinus” segment monetizes

What is the relevant market segment?

“Children’s Advil Allergy Sinus” competes within the OTC pediatric and family segment for:

• allergy symptom relief,
• congestion and “sinus” symptom relief,
• pain and fever reduction (via analgesic components),
• convenience-driven demand during seasonal peaks.

The segment’s economics are typically driven by:

• seasonal seasonality (spring and fall waves),
• retail velocity and planogram placement,
• brand trust and label-specific claims,
• pediatric dosing packaging and compliance.

How pricing and share usually work in this category

OTC allergy and sinus products price through a mix of:

• ingredient cost and formulation complexity,
• channel mix (mass, drugstore, club, online),
• competitive set (store brands plus branded combinations),
• promotional cadence.

Market share in OTC is rarely determined by “clinical differentiation” because OTC efficacy is largely label-based and governed by monograph or approved labeling pathways. Instead, share depends on:

• label scope (which symptoms the product is indicated for),
• onset messaging,
• age-range clarity and dosing simplicity,
• availability of liquid/gels/syrups aligned with pediatric preference.

Actionable analyst note: for investment or R&D planning, competitive strategy should be built around label and differentiation at the Drug Facts level, not around prospective randomized trials for a branded combination.

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Market Projection: demand, growth, and constraints

What growth levers matter for pediatric OTC allergy and sinus products?

For pediatric OTC allergy and sinus products, realistic growth levers are:

• population-level pediatric allergy prevalence and diagnosis patterns,
• retail expansion and online ordering convenience,
• competitive substitution between brands and generics based on price-per-dose,
• regulatory continuity (labeling stability; no abrupt ingredient restrictions),
• safety perceptions after high-visibility public health guidance.

Key constraints typically include:

• ingredient-specific regulatory scrutiny (especially for pediatric dosing and decongestant use),
• adverse-event monitoring and labeling updates,
• shifting consumer preference toward non-drowsy formats or antihistamine-only approaches (depending on labeling and local practice).

Projection framework (what can be projected precisely vs. what cannot)

A quantified market projection requires:

• the exact active ingredients and strengths,
• the dosage form and pack size,
• the geographies covered (US only vs. US + international),
• the market definition used (national OTC pediatric allergy products; or the narrower “allergy plus sinus” subcategory),
• source-backed baseline revenue and unit sales for that SKU or that category.

With only the product name, a quantified projection would be non-auditable and would fail the “high-stakes” standard.

Therefore: no numeric market forecast is provided.

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Business Impact Map: where to focus

What should an R&D team or investor evaluate for this product class?

Even without trial updates, the highest-return diligence for this category is label and regulatory readiness:

• Active ingredient set: confirm whether it is analgesic-based plus antihistamine plus decongestant, or another combination.
• Pediatric age range: verify the labeled age eligibility and dosing intervals.
• Safety constraints: check boxed/label warnings relevant to pediatric use (ingredient class dependent).
• Seasonality exposure: confirm historical sales timing by retailer calendar.
• Substitution risk: quantify how often consumers switch to cheaper store brands during peak season.

What should marketers focus on

Market performance in this category is usually strengthened by:

• clear “sinus/congestion” symptom messaging that matches label indications,
• dosing ease for children,
• consistent availability and quick-ship online packaging.

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Key Takeaways

• “Children’s Advil Allergy Sinus” is an OTC pediatric combination product, and clinical trials are generally ingredient-level rather than branded-combination-level.
• A complete, source-verifiable clinical-trials update and quantified market projection cannot be produced accurately from the brand name alone because registry evidence and market definitions require the exact Drug Facts active ingredients, strengths, dosage form, and geography.
• For business decisions, the most actionable work is label and regulatory mapping at the Drug Facts level, followed by seasonality and channel analysis using auditable category baselines.

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FAQs

1) Does this product have a distinct phase-3 clinical trial program?

OTC pediatric combination products typically do not run branded phase-3 efficacy programs; evidence usually comes from ingredient-level clinical data and labeling pathways.

2) How do I find the right clinical trials for this product?

Use the exact active ingredients and strengths from the Drug Facts panel, then search trials by ingredient and fixed-dose combination where applicable.

3) What drives sales for pediatric allergy and sinus OTC products?

Seasonality, price-per-dose, label symptom scope, and pediatric dosing convenience are the dominant drivers.

4) What regulatory risks tend to affect pediatric OTC allergy and sinus products?

Ingredient-class safety scrutiny and pediatric labeling updates are the main risks, which can change demand via planogram and consumer trust.

5) What is the best way to model market projections for this category?

Define a precise market slice (by geography, dosage form, and symptom scope) and anchor the forecast to audited baseline category sales and pack-level conversion.

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References

[1] FDA. OTC Drug Products. US Food and Drug Administration. https://www.fda.gov/drugs/over-counter-otc-drugs
[2] ClinicalTrials.gov. Search results (ingredient-level evidence approach). https://clinicaltrials.gov/