CLINICAL TRIALS PROFILE FOR ADVIL ALLERGY AND CONGESTION RELIEF

505(b)(2) Clinical Trials for ADVIL ALLERGY AND CONGESTION RELIEF

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	NCT00487032 ↗	Differential Adrenoreceptor Mediated Tachyphylaxis and Upregulation	Completed	Brian J Lipworth	Phase 4	2008-05-01	The investigators wish to evaluate the onset of tolerance to nasal decongestants like oxymetazoline (available over the counter) and the mechanism of tolerance particularly with differential effects on alpha 1 and alpha 2 adrenoreceptors on the nose. The investigators will 'tease' out by using an alpha 1 blocker called Prazosin. The investigators hypothesize that alpha 1 receptors mediate arterial constriction and this will be captured by measuring nasal blood flow. The investigators also hypothesize that alpha 2 receptors mediate venous sinusoid constriction and this the investigators will capture by airflow parameters like Peak Nasal Inspiratory Flow, Rhinomanometry, Oscillometric indices etc.
OTC	NCT01448057 ↗	Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu	Completed	Novartis	Phase 3	2013-07-01	The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).
New Formulation	NCT03339726 ↗	Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold	Terminated	Johnson & Johnson Consumer Inc. (J&JCI)	Phase 2	2017-11-30	This will be a randomized, double-blind, placebo controlled, parallel-group Phase 2 study to evaluate the efficacy of a new formulation of phenylephrine HCl and a currently marketed phenylephrine HCl for relief of nasal congestion in subjects with naturally occurring cold symptoms.

All Clinical Trials for ADVIL ALLERGY AND CONGESTION RELIEF

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00115622 ↗	Study In Adults And Adolescents With Seasonal Allergic Rhinitis	Completed	GlaxoSmithKline	Phase 3	2004-12-01	The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
NCT00118729 ↗	Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of Action	Completed	GlaxoSmithKline	Phase 3	2005-04-01	Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. The purpose of this study is to evaluate the onset of action of an investigational nasal spray, GW685698X aqueous nasal spray, versus vehicle placebo nasal spray in the treatment of seasonal allergic rhinitis caused by ragweed following a single dose of treatment in controlled pollen concentrations in an allergen challenge chamber.
NCT00124137 ↗	Ultrafiltration Versus Intravenous (IV) Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: (UNLOAD)	Completed	CHF Solutions	N/A	2004-04-01	The purpose of this study is to compare patients who are suffering from heart failure and who are fluid overloaded to determine if ultrafiltration (UF) can remove more of the extra fluid as measured by weight loss while in the hospital and improve the patient's breathing.
NCT00124137 ↗	Ultrafiltration Versus Intravenous (IV) Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: (UNLOAD)	Completed	Nuwellis, Inc.	N/A	2004-04-01	The purpose of this study is to compare patients who are suffering from heart failure and who are fluid overloaded to determine if ultrafiltration (UF) can remove more of the extra fluid as measured by weight loss while in the hospital and improve the patient's breathing.
NCT00197262 ↗	Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)	Completed	GlaxoSmithKline	Phase 3	2005-08-01	Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as (hay fever), it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with seasonal allergic rhinitis (SAR) caused by ragweed pollen.

Clinical Trial Conditions for ADVIL ALLERGY AND CONGESTION RELIEF

Condition Name

Condition Name for ADVIL ALLERGY AND CONGESTION RELIEF
Intervention	Trials
Heart Failure	33
Allergic Rhinitis	28
Seasonal Allergic Rhinitis	14
Acute Heart Failure	14

Condition MeSH

Condition MeSH for ADVIL ALLERGY AND CONGESTION RELIEF
Intervention	Trials
Heart Failure	79
Rhinitis	79
Rhinitis, Allergic	67
Rhinitis, Allergic, Seasonal	32

Clinical Trial Locations for ADVIL ALLERGY AND CONGESTION RELIEF

Trials by Country

Trials by Country for ADVIL ALLERGY AND CONGESTION RELIEF
Location	Trials
United States	501
China	40
Spain	35
Italy	32
Canada	31

Trials by US State

Trials by US State for ADVIL ALLERGY AND CONGESTION RELIEF
Location	Trials
Texas	31
North Carolina	23
California	22
New York	20
Missouri	20

Clinical Trial Progress for ADVIL ALLERGY AND CONGESTION RELIEF

Clinical Trial Phase

Clinical Trial Phase for ADVIL ALLERGY AND CONGESTION RELIEF
Clinical Trial Phase	Trials
Phase 4	81
Phase 3	98
Phase 2/Phase 3	14

Clinical Trial Status

Clinical Trial Status for ADVIL ALLERGY AND CONGESTION RELIEF
Clinical Trial Phase	Trials
Completed	164
Recruiting	41
Not yet recruiting	40

Clinical Trial Sponsors for ADVIL ALLERGY AND CONGESTION RELIEF

Sponsor Name

Sponsor Name for ADVIL ALLERGY AND CONGESTION RELIEF
Sponsor	Trials
GlaxoSmithKline	17
Merck Sharp & Dohme Corp.	15
Bayer	9

Sponsor Type

Sponsor Type for ADVIL ALLERGY AND CONGESTION RELIEF
Sponsor	Trials
Other	315
Industry	168
NIH	8