Status:

COMPLETED

Long Term Safety Of GW685698X Via Nasal Biopsy

Lead Sponsor:

GlaxoSmithKline

Conditions:

Rhinitis, Allergic, Perennial

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with perennial all...

Detailed Description

A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray \[Nasonex®\] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqu...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • History of perennial allergic rhinitis of 2 years, with a documented positive allergen test to an appropriate allergen.
  • Female patients of child-bearing potential must be willing to consistently and correctly use an acceptable method of birth control.
  • Exclusion criteria:
  • Patients who require certain medications for their allergy.
  • Patients with serious medical problems.

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2007

    Estimated Enrollment :

    125 Patients enrolled

    Trial Details

    Trial ID

    NCT00224523

    Start Date

    September 1 2005

    End Date

    February 1 2007

    Last Update

    October 28 2016

    Active Locations (4)

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    Page 1 of 1 (4 locations)

    1

    GSK Investigational Site

    Leuven, Belgium, 3000

    2

    GSK Investigational Site

    Amsterdam, Netherlands, 1105 AZ

    3

    GSK Investigational Site

    Nijmegen, Netherlands, 6525 EX

    4

    GSK Investigational Site

    The Hague, Netherlands, 2566 MJ