Last Updated: May 14, 2026

CLINICAL TRIALS PROFILE FOR SUDAFED 12 HOUR


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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.
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 12 HOUR

Condition Name

Condition Name for SUDAFED 12 HOUR
Intervention Trials
Healthy 2
SHY-DRAGER SYNDROME 2
HYPERTENSION 1
Sinusitis 1
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Condition MeSH

Condition MeSH for SUDAFED 12 HOUR
Intervention Trials
Pure Autonomic Failure 3
Sinusitis 2
Shy-Drager Syndrome 2
Multiple System Atrophy 2
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Clinical Trial Locations for SUDAFED 12 HOUR

Trials by Country

Trials by Country for SUDAFED 12 HOUR
Location Trials
United States 7
India 1
Canada 1
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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
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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
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Clinical Trial Status

Clinical Trial Status for SUDAFED 12 HOUR
Clinical Trial Phase Trials
Completed 9
Not yet recruiting 1
Terminated 1
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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
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Sponsor Type

Sponsor Type for SUDAFED 12 HOUR
Sponsor Trials
Other 11
NIH 4
Industry 3
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Sudafed 12 Hour: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the clinical trial history for Sudafed 12 Hour?

Sudafed 12 Hour, marketed as an extended-release decongestant, has primarily been evaluated through regulatory submissions rather than independent clinical trials. The formulation includes pseudoephedrine, a vasoconstrictor targeting nasal congestion. Its approval process involved demonstrating bioequivalence and safety profiles consistent with regulatory standards.

No recent peer-reviewed clinical trials have been published examining new indications or extensive safety assessments specifically for Sudafed 12 Hour. Post-market surveillance data from the FDA’s Adverse Event Reporting System (FAERS) indicates no new safety signals have emerged since its launch.

How has the market for nasal decongestants evolved?

Market Overview

The global market for nasal decongestants was valued at approximately $2.3 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.2% from 2023 to 2030. The expansion driven by increasing demand for OTC remedies, rising allergic rhinitis prevalence, and heightened awareness of cold and allergy management.

Key Competitors and Alternatives

Product Name Formulation Price Range (USD) Regulatory Status Unique Selling Point
Sudafed 12 Hour Pseudoephedrine extended-release $8-12 (per pack) FDA-approved OTC Long-lasting relief, once every 12 hours
Sudafed PE Phenylephrine decongestant $6-10 OTC Alternative to pseudoephedrine, fewer regulatory restrictions
Afrin 12-Hour Oxymetazoline nasal spray $4-8 OTC Fast onset, 12-hour duration
Claritin-D 12 Hour Loratadine + pseudoephedrine $18-24 OTC Combination allergy relief

Regulatory Environment & Market Access

The US FDA classifies pseudoephedrine-based products under the Combat Methamphetamine Epidemic Act (CMEA), imposing restrictions on sales and record-keeping. This impacts OTC availability and influences consumer preferences toward phenylephrine-based products, which are not subject to the same restrictions.

What are the key market drivers and constraints?

Drivers

  • Rise in allergic rhinitis and sinusitis cases: Approximately 30 million Americans suffer from hay fever annually.
  • Consumer preference for long-acting formulations: Awareness of convenience boosts demand for 12-hour products.
  • OTC availability: Accessibility drives sales growth, especially among aging populations and working adults.

Constraints

  • Regulatory restrictions: In the US, pseudoephedrine sales are regulated, limiting OTC distribution.
  • Safety concerns: Pseudoephedrine's vasoconstrictive effects pose risks for hypertensive patients; safety monitoring remains critical.
  • Competition from phenylephrine: Lower regulatory burdens and aggressive marketing challenge pseudoephedrine products.

How is the market projected to perform?

Sales Forecast

By 2030, sales of long-acting nasal decongestants are expected to reach $3.8 billion globally, with pseudoephedrine products maintaining a significant share despite regulatory constraints.

Geographic Trends

  • North America: Dominates with 45% market share, driven by high allergy prevalence and regulatory oversight.
  • Europe: Growing at a CAGR of 4%, with expanding OTC markets.
  • Asia-Pacific: Expected growth rate of 6%, reflecting increased urban pollution and allergy awareness.

Innovation and Investment Outlook

Industry investment prioritizes reformulation efforts, including combination therapies and new delivery mechanisms intending to bypass regulatory hurdles. The development of non-vasoconstrictive nasal sprays and oral alternatives is ongoing.

What are the implications for stakeholders?

Manufacturers should focus on regulatory strategies, including compliance and alternative formulations. Marketing should emphasize the product's long-lasting efficacy, safety profile, and convenience. Regulatory changes, particularly in the US, could alter market dynamics, favoring phenylephrine-based solutions.

Key Takeaways

  • Clinical data on Sudafed 12 Hour is limited; existing approvals rely on bioequivalence and safety assessments.
  • The nasal decongestant market is expanding, driven by allergy prevalence and consumer preference for OTC, long-lasting formulations.
  • Pseudoephedrine carries regulatory restrictions affecting accessibility; phenylephrine alternatives are gaining market share.
  • Market projections anticipate steady growth, reaching nearly $3.8 billion globally by 2030, with significant regional differences.
  • Innovation in delivery methods and formulation could reshape product positioning amid regulatory and safety considerations.

FAQs

1. Is there recent clinical research supporting Sudafed 12 Hour’s effectiveness?
No published recent clinical trials specifically evaluate Sudafed 12 Hour; its efficacy is supported by regulatory filings and existing safety data.

2. Will regulatory changes impact the availability of pseudoephedrine-based products?
Yes. The US CMEA restricts pseudoephedrine sales, potentially reducing OTC access and shifting demand toward phenylephrine-based products.

3. How does Sudafed 12 Hour compare in safety to other decongestants?
It has an established safety profile but is contraindicated for hypertensive patients due to vasoconstrictive effects, similar to other pseudoephedrine products.

4. What demographic segments show the highest demand for long-acting nasal decongestants?
Adults aged 25-50, especially those with seasonal allergies, sinusitis, or frequent cold episodes, represent the primary consumers.

5. Are there innovations expected in the nasal decongestant market?
Yes. Research focuses on non-vasoconstrictive formulations, combination therapies, and alternative delivery formats to enhance safety and compliance.


References

[1] Grand View Research. (2023). Nasal Decongestants Market Size, Share & Trends Analysis Report.
[2] U.S. Food and Drug Administration. (2022). Pseudoephedrine Drug Safety and Regulatory Information.
[3] Substance Abuse and Mental Health Services Administration. (2022). Combat Methamphetamine Epidemic Act of 2005.
[4] MarketWatch. (2023). Global Nasal Spray Market Outlook.
[5] IQVIA. (2022). OTC Consumer Health Market Trends.

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