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Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)

7. februar 2022 opdateret af: Organon and Co

A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Combination Montelukast/Loratadine in Patients With Seasonal Allergic Rhinitis-Fall Study

This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

907

Fase

  • Fase 3

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

15 år til 85 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patient has a documented history of seasonal 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 less than 8 weeks postpartum or is breast-feeding
  • Patient intends to move or vacation away during the study
  • Patient has had any major surgery within 4 weeks of study start
  • Patient is a current or past abuser of alcohol or illicit drugs
  • Patient has been treated in an emergency room for asthma in the past month
  • Patient had an upper respiratory infection with in 3 weeks prior to study start
  • Patient has any active pulmonary disorder other than asthma

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 4
placebo
Medicin: Comparator: placebo
placebo tablet taken once daily at bed time for 2 weeks
Eksperimentel: 3
montelukast
Medicin: Comparator: montelukast
montelukast 10 mg tablet taken once daily at bed time for 2 weeks
Eksperimentel: 1
montelukast/loratadine
Medicin: Comparator: montelukast/loratadine
montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks
Eksperimentel: 2
loratadine
Medicin: Comparator: loratadine
loratadine 10 mg tablet taken once daily at bed time for 2 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change From Baseline in Daytime Nasal Symptoms Score
Tidsramme: Baseline and Week 2
Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
Baseline and Week 2

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lægens globale evaluering af allergisk rhinitis
Tidsramme: Uge 2
En vurdering foretaget af lægen, administreret ved det sidste besøg (eller ved seponering) ved hjælp af en 7-trins skala, af ændringen i symptomer sammenlignet med begyndelsen af ​​undersøgelsen. Svarene blev tildelt numeriske værdier fra 0 (meget bedre) til 6 (meget dårligere).
Uge 2
Mean Change From Baseline in Nighttime Symptoms Score
Tidsramme: Baseline and Week 2
Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
Baseline and Week 2
Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)
Tidsramme: Baseline and Week 2
Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).
Baseline and Week 2
Mean Change From Baseline in Daytime Eye Symptoms Score
Tidsramme: Baseline and Week 2
Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom 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.
Baseline and Week 2
Mean Change From Baseline in Daytime Nasal Congestion Score
Tidsramme: Baseline and Week 2
Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).
Baseline and Week 2
Mean Change From Baseline in Daytime Rhinorrhea Score
Tidsramme: Baseline and Week 2
Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).
Baseline and Week 2
Mean Change From Baseline in Daytime Nasal Itching Score
Tidsramme: Baseline and Week 2
Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).
Baseline and Week 2
Mean Change From Baseline in Daytime Sneezing Score
Tidsramme: Baseline and Week 2
Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).
Baseline and Week 2
Mean Change From Baseline in Nasal Congestion Upon Awakening
Tidsramme: Baseline and Week 2
Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).
Baseline and Week 2
Patient's Global Evaluation of Allergic Rhinitis
Tidsramme: Week 2
An evaluation by the patient, 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).
Week 2
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score
Tidsramme: Week 2
Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.
Week 2

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Organon and Co

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 1999

Primær færdiggørelse (Faktiske)

1. november 1999

Studieafslutning (Faktiske)

1. november 1999

Datoer for studieregistrering

Først indsendt

19. august 2009

Først indsendt, der opfyldte QC-kriterier

20. august 2009

Først opslået (Skøn)

21. august 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0476A-117
  • MK0476A-117
  • 2009_645

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sæsonbestemt allergisk rhinitis

Kliniske forsøg med Comparator: montelukast/loratadine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Israel

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner