Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184)

NCT ID: NCT03861559

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-03-30
• Study Completion Date: 1994-07-07

Brief Summary

This study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo for 14 days.

Conditions

Rhinitis, Allergic, Seasonal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

mometasone furoate nasal spray

Participants administered mometasone furoate nasal spray 200 mcg once daily (QD), as two 50 mcg sprays per nostril, for 14 consecutive days.

Group Type: EXPERIMENTAL

mometasone furoate nasal spray

Intervention Type: DRUG

intranasal administration

placebo nasal spray

Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.

Group Type: PLACEBO_COMPARATOR

placebo nasal spray

Intervention Type: DRUG

intranasal administration

Interventions

mometasone furoate nasal spray

intranasal administration

Intervention Type: DRUG

placebo nasal spray

intranasal administration

Intervention Type: DRUG

Other Intervention Names

NASONEX®; MK-0887; SCH 032088

Eligibility Criteria

Inclusion Criteria

• Has a 2-year history of seasonal allergic rhinitis
• Has a positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
• Is in good health and free of any unstable, clinically-significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

Exclusion Criteria

• Women who are pregnant or breastfeeding
• Women of childbearing potential who are not using an acceptable form of birth control
• Has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn, or nedocromil
• Has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study, or required treatment which might interfere with the study
• Is on immunotherapy with the exception of maintenance therapy
• Has a clinically significant upper respiratory or sinus infection
• Has used an investigational drug within the previous 30 days
• Has nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
• Has a history of multiple drug allergies or an allergy to antihistamines or corticoids
• Has dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
• Has rhinitis medicamentosa
• Is using of any chronic medication which could affect the course of seasonal allergic rhinitis

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

C93-184

Identifier Type: OTHER

Identifier Source: secondary_id

C93-184

Identifier Type: -

Identifier Source: org_study_id