Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

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Organon

Status and phase

Completed
Phase 3

Conditions

Perennial Allergic Rhinitis

Treatments

Drug: Comparator: placebo
Drug: montelukast sodium
Drug: Comparator: cetirizine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00974571
MK0476-246
2009_659
0476-246

Details and patient eligibility

About

This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.

Enrollment

1,365 patients

Sex

All

Ages

15 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient has a documented clinical history of perennial allergic rhinitis
  • 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 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

1,365 participants in 3 patient groups, including a placebo group

1
Experimental group
Description:
montelukast
Treatment:
Drug: montelukast sodium
2
Active Comparator group
Description:
cetirizine
Treatment:
Drug: Comparator: cetirizine
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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