Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)
1 other identifier
interventional
679
0 countries
N/A
Brief Summary
The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages 6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 1996
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 1996
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 1996
CompletedFirst Submitted
Initial submission to the registry
March 15, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedResults Posted
Study results publicly available
August 12, 2019
CompletedFebruary 9, 2022
February 1, 2022
4 months
March 15, 2019
June 27, 2019
February 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator
The mean change from baseline at study day 8 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.
Baseline (Day 1) and Day 8
Secondary Outcomes (5)
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator
Baseline (Day 1) and Day 4
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator
Baseline (Day 1) and Day 15
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator
Baseline (Day 1) and Day 29
Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant
Baseline and Days 1 through 15 (average over 15 days)
Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant
Baseline and Days 16 through 29 (average over 15 days)
Study Arms (5)
MFNS 25 mcg QD
EXPERIMENTALMometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 100 mcg QD
EXPERIMENTALMometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
MFNS 200 mcg QD
EXPERIMENTALMometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
BDP 84 mcg BID
ACTIVE COMPARATORBeclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Placebo
PLACEBO COMPARATORMatching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Interventions
intranasal administration
intranasal administration
oral administration
Eligibility Criteria
You may qualify if:
- Have at least a one-year history of seasonal allergic rhinitis which previously required treatment for tree and/or grass pollen
- Have a positive skin test response to an appropriate tree and/or grass seasonal allergen within the last year.
- Must be free of any clinically significant disease other than seasonal allergic rhinitis.
- Must be pre-menarcheal.
You may not qualify if:
- History of asthma which requires chronic use of inhaled or systemic corticosteroids.
- Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
- History of rhinitis medicamentosa.
- History of clinically significant nasal candidiasis.
- History of multiple drug allergies or allergy/intolerance to corticosteroids or antihistamines.
- History of upper respiratory tract or sinus infection that required antibiotic therapy within the previous 2 weeks, or viral upper respiratory infection within 7 days prior to Screening.
- History of nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow.
- History of dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines.
- History of investigational drug use in the last 30 days.
- History of immunotherapy (desensitizing therapy), unless on a stable maintenance schedule for at least one month prior to Screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Adverse Event (AE) Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 21.1.
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2019
First Posted
March 19, 2019
Study Start
March 12, 1996
Primary Completion
July 1, 1996
Study Completion
July 1, 1996
Last Updated
February 9, 2022
Results First Posted
August 12, 2019
Record last verified: 2022-02