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Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)

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ClinicalTrials.gov Identifier: NCT00972738
Recruitment Status : Completed
First Posted : September 7, 2009
Results First Posted : June 16, 2010
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 4, 2009
First Posted Date  ICMJE September 7, 2009
Results First Submitted Date  ICMJE September 15, 2009
Results First Posted Date  ICMJE June 16, 2010
Last Update Posted Date July 23, 2015
Study Start Date  ICMJE April 2001
Actual Primary Completion Date July 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2010)
Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period [ Time Frame: Baseline and over the 2-week treatment period ]
Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2009)
Mean change From Baseline in Daytime Nasal Symptoms Score. [ Time Frame: 2-week treatment period ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2010)
  • Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period [ Time Frame: Baseline and over the 2-week treatment period ]
    Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score.
  • Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period [ Time Frame: Baseline and over the 2-week treatment period ]
    Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale [0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.
  • Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period [ Time Frame: End of the 2-week treatment period ]
    An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.
  • Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period [ Time Frame: End of the 2-week treatment period ]
    An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.
  • Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period [ Time Frame: Baseline and at the end of 2-week treatment period ]
    Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life Questionnaire, which included 28 questions on a 7-point scale [Score 0 (best) to 6 (worst)], across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2009)
  • Mean change From Baseline in Nighttime Symptoms Score [ Time Frame: 2-week treatment period ]
  • Mean change From Baseline in Daytime Eye Symptoms score [ Time Frame: 2-week treatment period ]
  • Patient's Global Evaluation of Allergic Rhinitis [ Time Frame: 2-week treatment period ]
  • Physician's Global Evaluation of Allergic Rhinitis [ Time Frame: 2-week treatment period ]
  • Mean change from baseline in Rhinoconjunctivitis Quality-of-Life score [ Time Frame: 2-week treatment period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)
Official Title  ICMJE A Multi-Center, Double-blind, Randomized, Parallel-Group Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Spring 2001 Study
Brief Summary This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Seasonal Allergic Rhinitis
Intervention  ICMJE
  • Drug: montelukast sodium
    Montelukast 10-mg tablet orally once daily at bedtime for 2 weeks.
  • Drug: Comparator: loratadine
    Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.
  • Drug: Comparator: Placebo
    placebo tablet orally once daily at bedtime for 2 weeks
Study Arms  ICMJE
  • Experimental: 1
    montelukast
    Intervention: Drug: montelukast sodium
  • Active Comparator: 2
    loratadine
    Intervention: Drug: Comparator: loratadine
  • Placebo Comparator: 3
    placebo
    Intervention: Drug: Comparator: Placebo
Publications * van Adelsberg J, Philip G, LaForce CF, Weinstein SF, Menten J, Malice MP, Reiss TF; Montelukast Spring Rhinitis Investigator Group. Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2003 Feb;90(2):214-22.

*   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: September 4, 2009)
1214
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2001
Actual Primary Completion Date July 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient has a documented history of season allergic rhinitis symptoms that flare up during the study season
  • Patient is a nonsmoker
  • Patient is in good general health

Exclusion Criteria:

  • Patient is hospitalized
  • Patient is a woman who is <8 weeks postpartum or is breast-feeding
  • Patient has had major surgery in the past 4 weeks
  • Patient intends to move or vacation away during the study
  • Patient is a current or past abuser of alcohol or illicit drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 85 Years   (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 NCT00972738
Other Study ID Numbers  ICMJE 0476-235
MK0476-235
2009_658
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 Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date July 2015

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