NCT00771160

Brief Summary

A clinical study evaluates the efficacy and safety of MK0476 in adult patients with Perennial Allergic rhinitis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2008

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

October 10, 2008

Last Update Submit

August 12, 2024

Conditions

Rhinitis, Allergic

Outcome Measures

Primary Outcomes (1)

  • Any clinical or laboratory adverse experience

    12 weeks

Secondary Outcomes (1)

  • The daily mean of the composite nasal symptoms score at each of biweekly visits during the treatment period (average over the previous 2 weeks) or at time of termination

    12 weeks

Study Arms (2)

1

EXPERIMENTAL

MK0476 5mg

Drug: montelukast sodium

2

EXPERIMENTAL

MK0476 10mg

Drug: montelukast sodium

Interventions

montelukast sodiumDRUG

Arm 1: montelukast tablet 5 mg, QD. Treatment period is 12-weeks. Arm 2: montelukast tablet 10 mg, QD. Treatment period is 12-weeks.

Also known as: Singulair
12

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Patients With Perennial Allergic Rhinitis

You may not qualify if:

  • Patients Who Have Nasal Diseases (E.G., Nasal Polyp, Septonasal Arcuation, Hypertrophic Rhinitis), Upper Respiratory Infection, Sinusitis, Infectious Rhinitis And Those Disease Severe Enough To Interfere With Assessment Of Effectiveness
  • Patients Who Have Rhinitis Medicamentosa, Or Nonallergic Rhinitis (E.G., Vasomotor Rhinitis, Eosinophilia Rhinitis)
  • Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

montelukast

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2008

First Posted

October 13, 2008

Study Start

September 1, 2004

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

August 15, 2024

Record last verified: 2022-02