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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)

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ClinicalTrials.gov Identifier: NCT03879772
Recruitment Status : Completed
First Posted : March 19, 2019
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE March 19, 2019
Results First Submitted Date  ICMJE June 27, 2019
Results First Posted Date  ICMJE August 12, 2019
Last Update Posted Date August 12, 2019
Actual Study Start Date  ICMJE March 12, 1996
Actual Primary Completion Date July 1, 1996   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator [ Time Frame: Baseline (Day 1) and Day 8 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator [ Time Frame: Baseline (Day 1) and Day 8 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator [ Time Frame: Baseline (Day 1) and Day 4 ]
    The mean change from baseline at study day 4 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.
  • Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator [ Time Frame: Baseline (Day 1) and Day 15 ]
    The mean change from baseline at study day 15 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.
  • Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator [ Time Frame: Baseline (Day 1) and Day 29 ]
    The mean change from baseline at study day 29 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.
  • 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 [ Time Frame: Baseline and Days 1 through 15 (average over 15 days) ]
    Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.
  • 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 [ Time Frame: Baseline and Days 16 through 29 (average over 15 days) ]
    Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Change From Baseline in the Total Nasal Symptom Score on Day 4 as Assessed by Investigator [ Time Frame: Baseline (Day 1) and Day 4 ]
  • Change From Baseline in the Total Nasal Symptom Score on Day 15 as Assessed by Investigator [ Time Frame: Baseline (Day 1) and Day 15 ]
  • Change From Baseline in the Total Nasal Symptom Score on Day 29 as Assessed by Investigator [ Time Frame: Baseline (Day 1) and Day 29 ]
  • Change From Baseline in the Total Nasal Symptom Score Averaged Over Days 1 to 15 as Assessed by Participant [ Time Frame: Baseline (Day 1) and Days 1 through 15 (average over 15 days) ]
  • Change From Baseline in the Total Nasal Symptom Score Averaged Over Days 16 to 29 as Assessed by Participant [ Time Frame: Baseline (Day 1) and Days 16 through 29 (average over 15 days) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE Dose-Ranging Study of Mometasone Furoate Nasal Spray (SCH 32088) in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (Protocol C95-161)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rhinitis, Allergic, Seasonal
Intervention  ICMJE
  • Drug: Mometasone furoate nasal spray
    intranasal administration
    Other Names:
    • Nasonex®
    • MK-0887
    • SCH 032088
  • Drug: Beclomethasone dipropionate nasal spray
    intranasal administration
    Other Name: Vancenase®
  • Drug: Placebo nasal spray
    intranasal administration
  • Drug: Chlorpheniramine maleate syrup
    oral administration
    Other Name: ChlorTrimeton Syrup
Study Arms  ICMJE
  • Experimental: MFNS 25 mcg QD
    Mometasone 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.
    Interventions:
    • Drug: Mometasone furoate nasal spray
    • Drug: Placebo nasal spray
    • Drug: Chlorpheniramine maleate syrup
  • Experimental: MFNS 100 mcg QD
    Mometasone 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.
    Interventions:
    • Drug: Mometasone furoate nasal spray
    • Drug: Placebo nasal spray
    • Drug: Chlorpheniramine maleate syrup
  • Experimental: MFNS 200 mcg QD
    Mometasone 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.
    Interventions:
    • Drug: Mometasone furoate nasal spray
    • Drug: Placebo nasal spray
    • Drug: Chlorpheniramine maleate syrup
  • Active Comparator: BDP 84 mcg BID
    Beclomethasone 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.
    Interventions:
    • Drug: Beclomethasone dipropionate nasal spray
    • Drug: Chlorpheniramine maleate syrup
  • Placebo Comparator: Placebo
    Matching 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:
    • Drug: Placebo nasal spray
    • Drug: Chlorpheniramine maleate syrup
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2019)
679
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 1996
Actual Primary Completion Date July 1, 1996   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03879772
Other Study ID Numbers  ICMJE C95-161
C95-161 ( Other Identifier: Schering-Plough Protocol Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP