You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR SUDAFED 24 HOUR


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Sudafed 24 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.
NCT00223691 ↗ Treatment of Orthostatic Hypotension in Autonomic Failure Completed Vanderbilt University Phase 1 2002-03-01 The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
NCT00223691 ↗ Treatment of Orthostatic Hypotension in Autonomic Failure Completed Vanderbilt University Medical Center Phase 1 2002-03-01 The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sudafed 24 Hour

Condition Name

Condition Name for Sudafed 24 Hour
Intervention Trials
Healthy 2
SHY-DRAGER SYNDROME 2
Scoliosis 1
Seasonal Allergic Rhinitis 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Sudafed 24 Hour
Intervention Trials
Pure Autonomic Failure 3
Sinusitis 2
Shy-Drager Syndrome 2
Multiple System Atrophy 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Sudafed 24 Hour

Trials by Country

Trials by Country for Sudafed 24 Hour
Location Trials
United States 7
Canada 1
India 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Sudafed 24 Hour
Location Trials
Tennessee 3
New York 1
Pennsylvania 1
Missouri 1
California 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Sudafed 24 Hour

Clinical Trial Phase

Clinical Trial Phase for Sudafed 24 Hour
Clinical Trial Phase Trials
Phase 4 1
Phase 2 1
Phase 1 3
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Sudafed 24 Hour
Clinical Trial Phase Trials
Completed 9
Terminated 1
Not yet recruiting 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Sudafed 24 Hour

Sponsor Name

Sponsor Name for Sudafed 24 Hour
Sponsor Trials
Vanderbilt University 3
Vanderbilt University Medical Center 2
Ranbaxy Laboratories Limited 2
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Sudafed 24 Hour
Sponsor Trials
Other 11
NIH 4
Industry 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials, Market Analysis, and Projections for SUDAFED 24 Hour

Introduction to SUDAFED 24 Hour

SUDAFED 24 Hour, a product line from the well-known brand SUDAFED, is widely used for relieving sinus congestion and pressure. The primary active ingredient in these products is pseudoephedrine, a nasal decongestant that helps reduce nasal swelling and inflammation to improve breathing.

Clinical Trials and Efficacy Concerns

Efficacy of Decongestants

Recent discussions around the efficacy of decongestants, particularly those containing phenylephrine, have raised questions about the overall effectiveness of these medications. An FDA advisory committee found that phenylephrine, another common decongestant, works no better than a placebo in relieving congestion[1].

However, pseudoephedrine, the active ingredient in SUDAFED 24 Hour, has been shown to be more effective in clinical settings. Pseudoephedrine-containing products, such as SUDAFED Sinus Congestion Relief, are known for their ability to temporarily relieve sinus pressure and nasal congestion[5].

Safety Concerns and Regulatory Updates

The European Medicines Agency (EMA) has recently updated guidelines for pseudoephedrine-containing medicines due to concerns about rare but serious side effects. These include posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), which can involve reduced blood supply to the brain. The EMA has recommended that these medicines not be used in patients with severe or uncontrolled hypertension or severe acute or chronic kidney disease[4].

Ongoing Clinical Investigations

While SUDAFED 24 Hour itself is not under new clinical trials, the broader category of common cold treatments is seeing ongoing research. Several newly developed products are currently under investigation to evaluate their efficacy and safety, which may influence future formulations or alternatives in the decongestant market[3].

Market Analysis

Current Market Size and Growth

The global decongestant market, which includes products like SUDAFED 24 Hour, was valued at US$ 15.73 billion in 2022. It is projected to reach US$ 24.67 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.6% during the forecast period. This growth is driven by the increasing prevalence of colds, sinusitis, and allergies worldwide[2].

Regional Insights

North America currently dominates the decongestant market due to high healthcare spending and growing awareness about cold relief products. However, the Asia Pacific region is expected to emerge as the fastest-growing market, driven by an expanding patient population and rapid economic development in countries like India and China[2].

Product Segmentation

The decongestant market is segmented by product type, with oral decongestants (like SUDAFED 24 Hour) being a significant segment. These products are available both over-the-counter (OTC) and by prescription. The market is also segmented by mode of action, application, and distribution channel, with nasal sprays and tablets being popular forms of decongestants[2].

Market Projections

Future Growth Drivers

The growth of the decongestant market, including products like SUDAFED 24 Hour, is expected to be driven by several factors:

  • Increasing Prevalence of Respiratory Issues: The rising incidence of colds, sinusitis, and allergies will continue to drive demand for decongestants.
  • Advancements in Formulations: New formulations and delivery methods, such as extended-release tablets, could enhance the market.
  • Expanding Distribution Channels: Online pharmacies and e-commerce platforms are making decongestants more accessible, contributing to market growth[2].

Competitive Landscape

The decongestant market is highly competitive, with major players such as Johnson & Johnson, Pfizer Inc., GlaxoSmithKline plc, and Novartis AG. SUDAFED, being a well-established brand, maintains a strong position in the market, particularly among oral OTC decongestants[2].

Regulatory Environment

FDA and EMA Guidelines

The FDA and EMA have been scrutinizing the safety and efficacy of decongestants. The FDA’s Accelerated Approval Program, which allows for faster approval based on surrogate endpoints, has been a topic of discussion. There is a push for more stringent post-market requirements to ensure the long-term safety and efficacy of these drugs[1].

Safety Warnings and Restrictions

As mentioned earlier, the EMA has updated product information for pseudoephedrine-containing medicines to include warnings about PRES and RCVS. These updates are crucial for ensuring patient safety and will likely influence how these products are prescribed and used[4].

Consumer Preferences and Awareness

Non-Drowsy and Extended-Release Formulations

Consumers increasingly prefer non-drowsy and extended-release formulations, which provide longer-lasting relief without the side effect of drowsiness. SUDAFED 24 Hour, with its pseudoephedrine HCl, fits this consumer preference by offering powerful, non-drowsy relief from sinus congestion[5].

Health Awareness and Education

Growing health awareness and education about cold relief products are driving the market. Consumers are more informed about the ingredients and potential side effects of decongestants, which can influence their purchasing decisions.

Key Takeaways

  • Efficacy and Safety: Pseudoephedrine, the active ingredient in SUDAFED 24 Hour, has been shown to be effective, but safety concerns such as PRES and RCVS need careful consideration.
  • Market Growth: The global decongestant market is projected to grow significantly, driven by increasing prevalence of respiratory issues and advancements in formulations.
  • Regulatory Environment: Stricter post-market requirements and updated safety warnings are shaping the regulatory landscape for decongestants.
  • Consumer Preferences: Non-drowsy and extended-release formulations are in high demand, aligning with the features of SUDAFED 24 Hour.

FAQs

What is the active ingredient in SUDAFED 24 Hour?

The active ingredient in SUDAFED 24 Hour is pseudoephedrine HCl, a nasal decongestant.

Are pseudoephedrine-containing medicines safe for everyone?

No, pseudoephedrine-containing medicines have safety concerns, particularly for patients with severe or uncontrolled hypertension or severe acute or chronic kidney disease. They should not be used in these cases due to the risk of PRES and RCVS[4].

How is the decongestant market expected to grow?

The decongestant market is expected to grow at a CAGR of 6.6% from 2022 to 2030, reaching US$ 24.67 billion by 2030[2].

What are the key drivers of the decongestant market growth?

Key drivers include the increasing prevalence of colds, sinusitis, and allergies, as well as advancements in formulations and expanding distribution channels[2].

Are there any ongoing clinical trials for new decongestant products?

Yes, several newly developed common cold products are currently under investigation to evaluate their efficacy and safety[3].

Sources

  1. Yale Medicine: "Phenylephrine, a Common Decongestant, Is Ineffective, Say FDA Advisors—It’s Not Alone."
  2. Coherent Market Insights: "Decongestant Market - Share, Size and Industry Analysis."
  3. JACI Global: "The common cold: The need for an effective treatment amid the FDA’s evolving regulatory landscape."
  4. EMA: "Pseudoephedrine-containing medicinal products - referral."
  5. SUDAFED: "SUDAFED® Sinus Congestion Relief Decongestant with Pseudoephedrine HCl."

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.