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

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Organon

Status and phase

Completed
Phase 3

Conditions

Seasonal Allergic Rhinitis

Treatments

Drug: Comparator: Placebo
Drug: montelukast sodium
Drug: Comparator: loratadine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00972738
2009_658
MK0476-235
0476-235

Details and patient eligibility

About

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.

Enrollment

1,214 patients

Sex

All

Ages

15 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,214 participants in 3 patient groups, including a placebo group

1
Experimental group
Description:
montelukast
Treatment:
Drug: montelukast sodium
2
Active Comparator group
Description:
loratadine
Treatment:
Drug: Comparator: loratadine
3
Placebo Comparator group
Description:
placebo
Treatment:
Drug: Comparator: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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