A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00960141
First received: August 14, 2009
Last updated: June 9, 2010
Last verified: June 2010
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Purpose
A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: montelukast sodium Drug: Comparator: loratadine Drug: Comparator: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Fall Study |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Mean Change From Baseline in Daytime Nasal Symptoms Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.
Secondary Outcome Measures:
- Mean Change From Baseline in Nighttime Symptoms Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]Mean change from baseline in Nighttime Symptoms Score on a 4-point scale [0(best) to 3(worst)]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score.
- Mean Change From Baseline in Daytime Eye Symptoms Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score.
- Patient's Global Evaluation of Allergic Rhinitis [ Time Frame: Week 2 (or upon discontinuation) ] [ Designated as safety issue: No ]An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, in answer to a single question regarding the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
- Physician's Global Evaluation of Allergic Rhinitis [ Time Frame: Week 2 ] [ Designated as safety issue: No ]An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
- Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]Patients completed a validated, self-administered 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 scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score.
| Enrollment: | 829 |
| Study Start Date: | August 2000 |
| Study Completion Date: | November 2000 |
| Primary Completion Date: | October 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
montelukast
|
Drug: montelukast sodium
montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks
|
|
Active Comparator: 2
loratadine
|
Drug: Comparator: loratadine
loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks
|
|
Placebo Comparator: 3
placebo
|
Drug: Comparator: placebo
placebo tablet, taken orally once daily at bed time for 2 weeks
|
Eligibility| Ages Eligible for Study: | 15 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
- Patient is a non-smoker
- Patient is in good mental and physical health
Exclusion Criteria:
- Patient is hospitalized
- Patient is a woman who is <8 weeks postpartum or is breast feeding
- Patient intends to move or vacation away during the study
- Patient is a current or past abuser of alcohol or illicit drugs
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00960141 History of Changes |
| Other Study ID Numbers: | 2009_633, MK0476-192 |
| Study First Received: | August 14, 2009 |
| Results First Received: | August 31, 2009 |
| Last Updated: | June 9, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections Loratadine Montelukast Antipruritics Dermatologic Agents Therapeutic Uses |
Pharmacologic Actions Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 16, 2013