CLINICAL TRIALS PROFILE FOR CLARINEX-D 12 HOUR

All Clinical Trials for Clarinex-d 12 Hour

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00636870 ↗	Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine	Completed	Sanofi	Phase 4	2003-02-01	To evaluate the single-dose and steady-state pharmacokinetics of desloratadine and fexofenadine in desloratadine slow metabolizers. To evaluate the safety and tolerability of desloratadine compared to fexofenadine following single and multiple oral doses administered to desloratadine slow metabolizers.
NCT00637585 ↗	Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine	Completed	Sanofi	Phase 4	2002-12-01	To examine the relative potency, onset of action and duration of action of fexofenadine HCl 180 mg (ALLEGRA) and desloratadine 5 mg (CLARINEX) as compared to placebo on skin wheals and flares induced by histamine.
NCT00757562 ↗	Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-11-01	This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or chronic hives. All of the subjects enrolled in this trial were previously identified in an earlier trial to be poor metabolizers of desloratadine.
NCT00783133 ↗	Preference for Clarinex Tablets vs. Allegra Tablets in Patients With Seasonal Allergies (Study P03177)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2002-11-01	This was a crossover study designed to see if patients with seasonal allergy symptoms preferred Clarinex® or Allegra®. Patients were randomized to take 7 days of Clarinex or Allegra treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Allegra, the patient prefers more.
NCT00794248 ↗	Preference for Clarinex Tablets vs. Allegra Tablets in Patients With Seasonal Allergies (Study P03179)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2002-11-01	This was a crossover study designed to see if patients with seasonal allergy symptoms preferred Clarinex® or Allegra®. Patients were randomized to take 7 days of Clarinex or Allegra treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Allegra, the patient prefers more.
NCT00794495 ↗	Preference for Clarinex Tablets vs. Zyrtec Tablets in Patients With Allergies (P03181)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2002-12-01	This was a crossover study designed to see if patients with allergy symptoms preferred Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.
NCT00794599 ↗	Preference for Clarinex Tablets vs. Zyrtec Tablets in Patients With Allergies (P03182)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2002-12-01	This was a crossover study designed to see if patients with allergy symptoms preferred Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.

Clinical Trial Conditions for Clarinex-d 12 Hour

Condition Name

Condition Name for Clarinex-d 12 Hour
Intervention	Trials
Seasonal Allergic Rhinitis	7
Healthy	5
Perennial Allergic Rhinitis	3
Allergic Rhinitis	2

Condition MeSH

Condition MeSH for Clarinex-d 12 Hour
Intervention	Trials
Rhinitis, Allergic	9
Rhinitis	9
Rhinitis, Allergic, Seasonal	7
Rhinitis, Allergic, Perennial	3

Clinical Trial Locations for Clarinex-d 12 Hour

Trials by Country

Trials by Country for Clarinex-d 12 Hour
Location	Trials
United States	8
Canada	2

Trials by US State

Trials by US State for Clarinex-d 12 Hour
Location	Trials
Florida	5
New Jersey	2
Kentucky	1

Clinical Trial Progress for Clarinex-d 12 Hour

Clinical Trial Phase

Clinical Trial Phase for Clarinex-d 12 Hour
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Clarinex-d 12 Hour
Clinical Trial Phase	Trials
Completed	18
Active, not recruiting	1

Clinical Trial Sponsors for Clarinex-d 12 Hour

Sponsor Name

Sponsor Name for Clarinex-d 12 Hour
Sponsor	Trials
Merck Sharp & Dohme Corp.	9
Dr. Reddy's Laboratories Limited	6
Sanofi	2

Sponsor Type

Sponsor Type for Clarinex-d 12 Hour
Sponsor	Trials
Industry	19
Other	1

Clarinex-D 12 Hour: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

Clarinex-D 12 Hour, a combination medication containing desloratadine and pseudoephedrine sulfate, was approved by the FDA in 2006 for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. This article delves into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials Overview

The FDA approval of Clarinex-D 12 Hour was based on the results of two clinical trials involving 1,248 patients aged 12 to 78 years with seasonal allergic rhinitis. Of these, 414 patients received Clarinex-D 12 Hour extended-release tablets twice daily for up to 2 weeks[1][4].

Efficacy

These trials demonstrated that Clarinex-D 12 Hour was significantly more effective than pseudoephedrine alone in relieving symptoms of allergic rhinitis excluding nasal congestion, and more effective than desloratadine alone in relieving nasal congestion. The bi-layer tablet delivery system ensured consistent release of the pseudoephedrine component, providing effective relief throughout the day[1][4].

Safety and Adverse Reactions

The clinical trials reported adverse reactions such as insomnia, headache, dry mouth, fatigue, somnolence, and pharyngitis. The incidence of these adverse events was generally comparable to or slightly lower than those experienced with pseudoephedrine alone. Only 3.6% of patients discontinued the trials due to adverse events[1][4].

Market Analysis

Market Need

Clarinex-D 12 Hour addresses a significant need in the allergy treatment market, particularly for patients who experience nasal congestion as the most bothersome symptom of allergic rhinitis. A survey of 1,000 adults with allergic rhinitis found that nearly 85% experience nasal congestion upon waking, making it a prevalent morning symptom[1].

Competitive Landscape

The allergy medication market is highly competitive, with various antihistamines and decongestants available. However, Clarinex-D 12 Hour's unique combination of desloratadine and pseudoephedrine, along with its extended-release formulation, positions it as a valuable option for patients seeking relief from both nasal and non-nasal symptoms without causing drowsiness[1][4].

Sales and Revenue

While specific current sales figures for Clarinex-D 12 Hour are not provided in the sources, the estimated U.S. sales for Clarinex-D 24 Hour, a related product, were significant, indicating a strong market presence for the Clarinex-D brand. For instance, the generic version of Clarinex-D 24 Hour, approved in 2011, reflected substantial market demand[3].

Market Projections

Growth Potential

Given the ongoing prevalence of seasonal allergic rhinitis and the specific needs of patients experiencing nasal congestion, Clarinex-D 12 Hour is likely to maintain a strong market presence. The convenience of a twice-daily dosing regimen and the lack of drowsiness associated with the medication are key factors that will continue to attract patients and healthcare providers.

Generic Competition

The approval of generic versions of Clarinex-D, such as the generic Clarinex-D 24 Hour approved in 2011, may impact the market share of the branded product. However, the brand's reputation and the specific formulation of Clarinex-D 12 Hour are expected to retain a loyal customer base[3].

Future Developments

As the pharmaceutical landscape evolves, there may be opportunities for further formulations or combinations that build upon the success of Clarinex-D 12 Hour. Innovations in delivery systems or additional indications could further enhance the product's market position.

Expert Insights

"For my patients who report nasal congestion along with other allergy symptoms, an antihistamine and decongestant combination treatment provides safe and effective relief," said William Lumry, M.D., Allergy & Asthma Specialists, Dallas, Texas. "With Clarinex-D 12 or 24 hour extended release tablets, I can now prescribe a 12- or 24-hour formulation that does not cause drowsiness and treats their nasal blockage effectively."[1]

Key Takeaways

• Clinical Efficacy: Clarinex-D 12 Hour is effective in relieving both nasal and non-nasal symptoms of seasonal allergic rhinitis.
• Safety Profile: The medication has a manageable adverse reaction profile, with common side effects including insomnia, headache, and dry mouth.
• Market Position: It addresses a significant market need for patients experiencing nasal congestion and is positioned well against competitors.
• Future Prospects: The product is likely to maintain its market presence despite generic competition, with potential for future innovations.

Frequently Asked Questions (FAQs)

What is Clarinex-D 12 Hour used for?

Clarinex-D 12 Hour is used for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older[1][4].

How is Clarinex-D 12 Hour administered?

Clarinex-D 12 Hour Extended Release Tablets should be taken orally, once every 12 hours, without breaking, chewing, or crushing the tablet[2][4].

What are the common side effects of Clarinex-D 12 Hour?

Common side effects include insomnia, headache, dry mouth, fatigue, somnolence, and pharyngitis[1][4].

Can Clarinex-D 12 Hour cause drowsiness?

No, Clarinex-D 12 Hour is designed to provide relief without causing drowsiness, making it a preferred option for many patients[1].

Is Clarinex-D 12 Hour available in generic form?

Yes, generic versions of Clarinex-D have been approved, but the branded product remains a popular choice due to its specific formulation and brand reputation[3].

Cited Sources:

1. Schering-Plough Corporation Says FDA Approves 12-Hour Clarinex - Biospace
2. Clarinex-D 12hr (Desloratadine and Pseudoephedrine Sulfate) - RxList
3. RxHighlights - Medicaid Nevada
4. Clarinex-D 12 Hour: Package Insert / Prescribing Information - Drugs.com
5. Application Number - accessdata.fda.gov - FDA

Last updated: 2025-01-02