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Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00319995
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : February 16, 2022
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Organon and Co

Brief Summary:
This is a Phase 3, randomized, parallel-group, multicenter, double-dummy, double-blind study with a screening period. Subjects will receive one of the following three treatment groups for 15 days: loratadine 10 mg/montelukast 10 mg combination, pseudoephedrine 240 mg, or placebo. The primary objective of this study is to assess the efficacy of the combination of loratadine/montelukast, a once-daily tablet containing 10 mg loratadine and 10 mg montelukast, compared with placebo in subjects with seasonal allergic rhinitis (SAR) in relieving the symptom of nasal congestion. The safety profile of combined loratadine/montelukast relative to placebo and pseudoephedrine will also be evaluated.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Drug: loratadine; montelukast Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1095 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Combination Loratadine/Montelukast QD vs Pseudoephedrine and Placebo in the Treatment of Subjects With Seasonal Allergic Rhinitis
Actual Study Start Date : March 1, 2006
Actual Primary Completion Date : June 1, 2006
Actual Study Completion Date : June 28, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged 15 years or older, of either sex and of any race.
  • At least a 2-year documented history of SAR with symptoms during the study season.
  • A positive skin-prick test response to seasonal
  • Clinically symptomatic at Screening and at the Baseline Visits
  • General good health.
  • Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluations.
  • Willingness (subjects and/or a parent/guardian) to give written informed consent and ability to adhere to dosing and visit schedules and meet study requirements.
  • Negative pregnancy test

Exclusion Criteria:

  • A history of anaphylaxis and/or other severe local reaction(s) to skin testing.
  • Asthma requiring chronic use of inhaled or systemic corticosteroids.
  • Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
  • Rhinitis medicamentosa.
  • A history of allergies to more than two classes of medications or allergy to or intolerance of antihistamines, montelukast, or pseudoephedrine.
  • An upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14 day washout prior to the Screening Visit, or a viral upper respiratory infection within 7 days before the Screening Visit.
  • Nasal structural abnormalities, including large nasal polyps and marked septal deviations, that significantly interfere with nasal air flow.
  • Dependence (in the opinion of the investigator) on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
  • Narrow-angle glaucoma, increased intraocular pressure, urinary retention, hypertension, severe coronary artery disease, ischemic heart disease, diabetes mellitus, hyperthyroidism, renal impairment, or prostatic hypertrophy, and those receiving monamine oxidase (MAO) inhibitor therapy.
  • Use of any drug in an investigational protocol in the 30 days before the Screening Visit.
  • Current immunotherapy (desensitization therapy), unless on a regular maintenance schedule prior to the Screening Visit, which should be maintained for the remainder of the study. No desensitization treatment within 24 hours before any visit.
  • Requirement for chronic use of tricyclic antidepressants.
  • Pregnancy or lactation.
  • Family member of the investigation study staff.
  • Current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject's participation in the study. Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism, or excretion of the study drug or interfere with the subject's ability to complete or reliably complete the diary card.
  • Significant medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment.
  • Compromised ability to provide informed consent..
  • A history of noncompliance with medications or treatment protocols.
Study Data/Documents: CSR Synopsis  This link exits the site

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Organon and Co Identifier: NCT00319995    
Other Study ID Numbers: P04095
Doc ID 3058224;
SCH 445761
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Respiratory Tract Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents