CLINICAL TRIALS PROFILE FOR SUDAFED 12 HOUR

All Clinical Trials for Sudafed 12 Hour

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002149 ↗	Acupuncture and Herbal Treatment of Chronic HIV Sinusitis	Completed	Immune Enhancement Project	N/A	1969-12-31	To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin ) in reducing symptoms and recurrence of acute HIV-related sinusitis. Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of life-threatening sepsis, and progress to central nervous system involvement. Symptoms of sinusitis in HIV patients are often refractory to aggressive Western medical management, and antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic therapy.
NCT00179023 ↗	The Autonomic Nervous System and Obesity	Completed	Vanderbilt University	Phase 1	2003-04-01	In its simplest terms, obesity is the results of a positive balance between food intake and energy expenditure (EE). I.e., we take in more energy, in the form of food, than we expend, e.g., by exercise. In our sedentary society, resting EE accounts for most of total energy expenditure. The sympathetic nervous system (SNS, the one that produces adrenaline) is thought to contribute to resting EE. This conclusion is based on experiments where resting EE is decreased by beta-blockers, high blood pressure medicines that block only one aspect of the sympathetic nervous system. The investigators propose to use a different approach, by using a medication called trimethaphan that produces transient withdrawal of the autonomic nervous system. The investigators will then compare the measured resting EE before and after SNS withdraw and quantify the degree of contribution to the resting EE by the SNS and delineate differences between healthy normal, healthy obese, and patients with autonomic dysfunctions.
NCT00179023 ↗	The Autonomic Nervous System and Obesity	Completed	Vanderbilt University Medical Center	Phase 1	2003-04-01	In its simplest terms, obesity is the results of a positive balance between food intake and energy expenditure (EE). I.e., we take in more energy, in the form of food, than we expend, e.g., by exercise. In our sedentary society, resting EE accounts for most of total energy expenditure. The sympathetic nervous system (SNS, the one that produces adrenaline) is thought to contribute to resting EE. This conclusion is based on experiments where resting EE is decreased by beta-blockers, high blood pressure medicines that block only one aspect of the sympathetic nervous system. The investigators propose to use a different approach, by using a medication called trimethaphan that produces transient withdrawal of the autonomic nervous system. The investigators will then compare the measured resting EE before and after SNS withdraw and quantify the degree of contribution to the resting EE by the SNS and delineate differences between healthy normal, healthy obese, and patients with autonomic dysfunctions.

Clinical Trial Conditions for Sudafed 12 Hour

Condition Name

Condition Name for Sudafed 12 Hour
Intervention	Trials
Healthy	2
Shy-Drager Syndrome	2
Seasonal Allergic Rhinitis	1

Condition MeSH

Condition MeSH for Sudafed 12 Hour
Intervention	Trials
Pure Autonomic Failure	3
Multiple System Atrophy	2
Sinusitis	2

Clinical Trial Locations for Sudafed 12 Hour

Trials by Country

Trials by Country for Sudafed 12 Hour
Location	Trials
United States	7
Canada	1
India	1

Trials by US State

Trials by US State for Sudafed 12 Hour
Location	Trials
Tennessee	3
New York	1
Pennsylvania	1
Missouri	1
California	1

Clinical Trial Progress for Sudafed 12 Hour

Clinical Trial Phase

Clinical Trial Phase for Sudafed 12 Hour
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1
Phase 1	3

Clinical Trial Status

Clinical Trial Status for Sudafed 12 Hour
Clinical Trial Phase	Trials
Completed	9
Terminated	1
Not yet recruiting	1

Clinical Trial Sponsors for Sudafed 12 Hour

Sponsor Name

Sponsor Name for Sudafed 12 Hour
Sponsor	Trials
Vanderbilt University	3
Vanderbilt University Medical Center	2
Ranbaxy Laboratories Limited	2

Sponsor Type

Sponsor Type for Sudafed 12 Hour
Sponsor	Trials
Other	11
NIH	4
Industry	3

Sudafed 12 Hour: Clinical Trials, Market Analysis, and Projections

Introduction to Sudafed 12 Hour

Sudafed 12 Hour, a product line from the well-known brand Sudafed, offers extended-release decongestant caplets designed to provide long-lasting relief from nasal congestion, sinus pressure, and other upper respiratory symptoms. This article will delve into the clinical trials, market analysis, and projections for Sudafed 12 Hour products.

Clinical Trials and Efficacy

Pseudoephedrine Efficacy

Clinical trials have consistently shown that pseudoephedrine, the active ingredient in Sudafed 12 Hour products, is highly effective in relieving nasal congestion. A placebo-controlled study published on PubMed highlighted that pseudoephedrine significantly improved measures of nasal congestion compared to phenylephrine and placebo over a 6-hour observation period[4].

In another context, the FDA has evaluated the efficacy of pseudoephedrine in various studies, confirming its effectiveness in reducing nasal congestion scores and improving peak nasal inspiratory flow[3].

Comparison with Other Decongestants

Studies comparing pseudoephedrine with other decongestants, such as phenylephrine, have shown that pseudoephedrine is more effective. For instance, a study involving patients with seasonal allergic rhinitis found that pseudoephedrine was significantly more effective than phenylephrine in reducing nasal congestion[4].

Product Variants and Active Ingredients

Sudafed Sinus Congestion 12 Hour Relief

This variant contains 120 mg of pseudoephedrine HCl per caplet, providing 12 hours of non-drowsy relief from nasal congestion and sinus pressure. It is suitable for adults and children aged 12 and older[1].

Sudafed Sinus 12 Hour Pressure + Pain Relief

This product combines 120 mg of pseudoephedrine HCl with 220 mg of naproxen sodium (an NSAID) to relieve sinus pressure, congestion, headaches, and minor body aches. It offers comprehensive relief for multiple cold, sinus, and flu symptoms[2].

Market Analysis

Current Market Size and Growth

The decongestant market, which includes products like Sudafed 12 Hour, was valued at US$ 15.73 billion in 2022. It is projected to grow at a CAGR of 6.60% to reach US$ 24.67 billion by 2030. This growth is driven by increasing demand for over-the-counter (OTC) medications and the prevalence of respiratory allergies and infections[5].

Key Players and Market Share

Sudafed, a brand owned by Johnson & Johnson, is one of the leading players in the decongestant market. Other major companies in this sector include Pfizer Inc., GlaxoSmithKline plc, and Novartis AG. The market is highly competitive, with multiple brands offering various decongestant products[5].

Market Projections

Increasing Demand for OTC Medications

The trend towards self-medication and the convenience of OTC products are expected to drive the demand for decongestants like Sudafed 12 Hour. As the global population grows and urbanization increases, the incidence of respiratory allergies and infections is likely to rise, further boosting the market[5].

Technological Advancements and Product Innovations

The decongestant market is expected to see innovations in formulation and delivery systems, such as extended-release formulations and combination products. Sudafed 12 Hour, with its 12-hour extended-release caplets, is already a leader in this segment. Future innovations could include more targeted therapies and improved patient compliance[5].

Consumer Preferences and Trends

Non-Drowsy and Long-Lasting Relief

Consumers increasingly prefer non-drowsy and long-lasting relief from nasal congestion and sinus pressure. Sudafed 12 Hour products cater to this demand by providing 12 hours of non-drowsy relief, making them a popular choice among consumers[1][2].

Combination Therapies

There is a growing trend towards combination therapies that address multiple symptoms simultaneously. The Sudafed Sinus 12 Hour Pressure + Pain Relief caplets, which combine a decongestant with an NSAID, are an example of this trend and are likely to remain popular[2].

Regulatory Considerations

FDA Oversight and Safety

The FDA closely monitors the safety and efficacy of OTC decongestants, including those containing pseudoephedrine. Studies and evaluations by the FDA have not identified significant safety issues with pseudoephedrine when used as directed[3].

Usage Guidelines and Warnings

It is crucial for consumers to follow the recommended dosage and usage guidelines for Sudafed 12 Hour products. These include not taking more than the recommended dose, avoiding use in children under 12, and consulting a doctor before use if certain health conditions are present[1][2].

Key Takeaways

• Clinical Efficacy: Pseudoephedrine in Sudafed 12 Hour products has been shown to be highly effective in clinical trials.
• Market Growth: The decongestant market is projected to grow significantly, driven by increasing demand for OTC medications.
• Product Innovations: Extended-release and combination products are expected to continue innovating the market.
• Consumer Preferences: Non-drowsy and long-lasting relief, along with combination therapies, are preferred by consumers.
• Regulatory Compliance: Adherence to FDA guidelines and usage recommendations is essential for safe and effective use.

FAQs

What is the active ingredient in Sudafed 12 Hour Sinus Congestion Relief?

The active ingredient is pseudoephedrine HCl, which provides 12 hours of non-drowsy relief from nasal congestion and sinus pressure[1].

Can Sudafed 12 Hour products be used by children?

Sudafed 12 Hour products are suitable for adults and children aged 12 and older. Children under 12 should not use these products[1][2].

What are the potential side effects of Sudafed 12 Hour products?

Potential side effects include nervousness, dizziness, and sleeplessness. If these symptoms occur or if symptoms do not improve within 7 days, consumers should consult a doctor[1][2].

Are Sudafed 12 Hour products available over-the-counter?

Yes, Sudafed 12 Hour products are available for in-store purchase only, behind the pharmacy counter, without a prescription[1][2].

Can Sudafed 12 Hour products be used by pregnant or breastfeeding women?

Pregnant or breastfeeding women should consult a health professional before using Sudafed 12 Hour products[1][2].

Sources

1. Sudafed.com - SUDAFED® 12-Hour Sinus Congestion Relief Decongestant Caplets
2. Sudafed.com - SUDAFED® 12-Hour Pressure + Pain Relief Decongestant Caplets
3. FDA.gov - FDA Briefing Document
4. PubMed - A placebo-controlled study of the nasal decongestant effect of pseudoephedrine and phenylephrine
5. Coherent Market Insights - Decongestant Market - Share, Size and Industry Analysis

Last updated: 2025-01-07