NCT00963599

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
907

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 1999

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, 1999

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1999

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 16, 2010

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

August 19, 2009

Results QC Date

August 31, 2009

Last Update Submit

February 7, 2022

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Daytime Nasal Symptoms Score

    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

Secondary Outcomes (11)

  • Mean Change From Baseline in Nighttime Symptoms Score

    Baseline and Week 2

  • Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)

    Baseline and Week 2

  • Mean Change From Baseline in Daytime Eye Symptoms Score

    Baseline and Week 2

  • Mean Change From Baseline in Daytime Nasal Congestion Score

    Baseline and Week 2

  • Mean Change From Baseline in Daytime Rhinorrhea Score

    Baseline and Week 2

  • +6 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL

montelukast/loratadine

Drug: Comparator: montelukast/loratadine

2

EXPERIMENTAL

loratadine

Drug: Comparator: loratadine

3

EXPERIMENTAL

montelukast

Drug: Comparator: montelukast

4

PLACEBO COMPARATOR

placebo

Drug: Comparator: placebo

Interventions

Comparator: montelukast/loratadineDRUG

montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks

1
Comparator: montelukastDRUG

montelukast 10 mg tablet taken once daily at bed time for 2 weeks

3
Comparator: loratadineDRUG

loratadine 10 mg tablet taken once daily at bed time for 2 weeks

2
Comparator: placeboDRUG

placebo tablet taken once daily at bed time for 2 weeks

4

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nayak AS, Philip G, Lu S, Malice MP, Reiss TF; Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall. Ann Allergy Asthma Immunol. 2002 Jun;88(6):592-600. doi: 10.1016/S1081-1206(10)61891-1.

    PMID: 12086367RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Loratadine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CyproheptadineDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2009

First Posted

August 21, 2009

Study Start

September 1, 1999

Primary Completion

November 1, 1999

Study Completion

November 1, 1999

Last Updated

February 9, 2022

Results First Posted

June 16, 2010

Record last verified: 2022-02