Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: April 28, 2006
Last updated: October 19, 2015
Last verified: October 2015
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.
Rhinitis, Allergic, Seasonal
Drug: loratadine; montelukast
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||Efficacy and Safety of Combination Loratadine/Montelukast QD vs Pseudoephedrine and Placebo in the Treatment of Subjects With Seasonal Allergic Rhinitis
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2006 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||15 Years and older (Child, Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
Doc ID 3058224;
|Study First Received:
||April 28, 2006
||October 19, 2015
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2016
Rhinitis, Allergic, Seasonal
Respiratory Tract Diseases
Respiratory Tract Infections
Immune System Diseases
Respiratory System Agents
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
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists