An Approved Drug to Study a New Indication for Allergic Rhinitis

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00127647

First received: August 4, 2005

Last updated: September 17, 2008

Last verified: September 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

August 4, 2005

Last Updated Date

September 17, 2008

Start Date ^ICMJE

November 2001

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Composite Nasal Symptom Score

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00127647 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Daytime nasal symptom score, Nighttime nasal symptom score

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Approved Drug to Study a New Indication for Allergic Rhinitis

Official Title ^ICMJE

MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis

Brief Summary

The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Rhinitis, Allergic, Seasonal

Intervention ^ICMJE

Drug: montelukast sodium
montelukast sodium; 5 mg, 10 mg QD 2-weeks.
Other Names:
- MK0476
- Singulair
Drug: Comparator: pranlukast
Pranlukast 225 mg BID 2-weeks.

Study Arm (s)

Experimental: 1
montelukast sodium 5 mg, QD 2-weeks

Intervention: Drug: montelukast sodium
Experimental: 2
montelukast sodium 10 mg QD 2-weeks

Intervention: Drug: montelukast sodium
Active Comparator: 3
Pranlukast 225 mg BID 2-weeks

Intervention: Drug: Comparator: pranlukast

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1375

Completion Date

Not Provided

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress)

Exclusion Criteria:

Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period

Gender

Both

Ages

15 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00127647

Other Study ID Numbers ^ICMJE

2005_038, MK0476-327

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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