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Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)

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ClinicalTrials.gov Identifier: NCT03855228
Recruitment Status : Completed
First Posted : February 26, 2019
Results First Posted : July 26, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE February 26, 2019
Results First Submitted Date  ICMJE May 29, 2019
Results First Posted Date  ICMJE July 26, 2019
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE March 1, 1995
Actual Primary Completion Date August 7, 1995   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) [ Time Frame: Baseline and days 1 through 15 (average of 15 days of treatment) ]
    Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute 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 was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
  • Change From Baseline in Total Symptom Score (Assessed by Participant) [ Time Frame: Baseline and days 1 through 15 (average of 15 days of treatment) ]
    Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute 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 was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
  • Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) [ Time Frame: Baseline and days 1 through 15 (average of 15 days of treatment) ]
  • Change From Baseline in Total Symptom Score (Assessed by Participant) [ Time Frame: Baseline and days 1 through 15 (average of 15 days of treatment) ]
Change History Complete list of historical versions of study NCT03855228 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician) [ Time Frame: Baseline and study day 15 ]
    The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
  • Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician) [ Time Frame: Baseline and study day 15 ]
    The mean change from baseline on study day 15 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
  • Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician) [ Time Frame: Baseline and study day 8 ]
    The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
  • Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician) [ Time Frame: Baseline and study day 8 ]
    The mean change from baseline on study day 8 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
  • Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician) [ Time Frame: Baseline and study day 15 ]
    The mean change from baseline on study day 15 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
  • Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician) [ Time Frame: Baseline and study day 8 ]
    The mean change from baseline on study day 8 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
  • Response to Therapy on Day 15 (Assessed by Physician) [ Time Frame: Study day 15 ]
    Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 15. A higher value indicates weaker response.
  • Response to Therapy on Day 8 (Assessed by Physician) [ Time Frame: Study day 8 ]
    Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 8. A higher value indicates weaker response.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
  • Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician) [ Time Frame: Baseline and day 15 ]
  • Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician) [ Time Frame: Baseline and day 15 ]
  • Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician) [ Time Frame: Baseline and day 8 ]
  • Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician) [ Time Frame: Baseline and day 8 ]
  • Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician) [ Time Frame: Baseline and day 15 ]
  • Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician) [ Time Frame: Baseline and day 8 ]
  • Response to Therapy on Day 15 (Assessed by Physician) [ Time Frame: Day 15 ]
  • Response to Therapy on Day 8 (Assessed by Physician) [ Time Frame: Day 8 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)
Official Title  ICMJE Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in the Treatment of Seasonal Allergic Rhinitis (Study No. C94-145)
Brief Summary The purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal spray (MFNS) with the addition of loratadine vs MFNS alone, loratadine alone, or placebo, in the treatment of patients with seasonal allergic rhinitis.
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
Intervention  ICMJE
  • Drug: Mometasone furoate nasal spray (MFNS)
    Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.
    Other Names:
    • SCH 32088
    • MK-0887
    • NASONEX®
  • Drug: Loratadine
    Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.
    Other Name: Claritin®
  • Drug: Placebo nasal spray
    Daily dose of placebo administered as a nasal spray for 15 days.
  • Drug: Placebo tablet
    Daily dose of placebo administered as an oral tablet for 15 days.
Study Arms  ICMJE
  • Experimental: MFNS 200 µg + Loratadine 10 mg
    Daily administration of 200 µg of MFNS plus oral dose of 10 mg loratadine tablet.
    Interventions:
    • Drug: Mometasone furoate nasal spray (MFNS)
    • Drug: Loratadine
  • Active Comparator: MFNS 200 µg
    Daily administration of 200 µg of MFNS plus oral placebo tablet.
    Interventions:
    • Drug: Mometasone furoate nasal spray (MFNS)
    • Drug: Placebo tablet
  • Active Comparator: Loratadine 10 mg
    Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
    Interventions:
    • Drug: Loratadine
    • Drug: Placebo nasal spray
  • Placebo Comparator: Placebo
    Daily administration of placebo nasal spray plus oral placebo tablet.
    Interventions:
    • Drug: Placebo nasal spray
    • Drug: Placebo tablet
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: February 25, 2019)
704
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 7, 1995
Actual Primary Completion Date August 7, 1995   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 2-year history of seasonal allergic rhinitis
  • Positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
  • 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
  • Significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study
  • Use of any chronic medication which could affect the course of seasonal allergic rhinitis
  • Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment)
  • Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip
  • Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection (URI) within the 7 days prior to Screening
  • Dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
  • Has rhinitis medicamentosa
  • Evidence of clinically significant nasal candidiasis
  • Investigational drug use within the previous 30 days
  • Nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
  • Immunotherapy (desensitization therapy), unless on a stable maintenance schedule for at least one month prior to the Screening visit
  • History of multiple drug allergies, allergy to antihistamines or corticoids
  • History of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
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 NCT03855228
Other Study ID Numbers  ICMJE C94-145
C94-145 ( Other Identifier: Schering-Plough Corporation 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 July 2019

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