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Clinical Trials/EUCTR2004-004744-43-NO
EUCTR2004-004744-43-NO
Active, not recruiting
Phase 1

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Vasomotor/Idiopathic Rhinitis

GlaxoSmithKline Research & Development Ltd0 sites347 target enrollmentFebruary 11, 2005

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Vasomotor/Idiopathic Rhinitis
Sponsor
GlaxoSmithKline Research & Development Ltd
Enrollment
347
Status
Active, not recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 11, 2005
End Date
February 9, 2006
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • Subject will be eligible for inclusion only if all of following criteria apply:
  • 1\. Informed consent
  • Subject has provided an appropriately signed and dated informed consent. An
  • appropriately signed and dated assent must be obtained from the parents or
  • guardian if the subject is a child under 18 years of age.
  • 2\. Subject is treatable on an outpatient basis.
  • 3\. Age \- \= 12 years at Visit 2
  • 4\. Male or eligible female
  • To be eligible for entry, females of childbearing potential must commit
  • to consistent and correct use of an acceptable method of birth control, as defined

Exclusion Criteria

  • Subject will not be eligible for inclusion if any of following criteria apply:
  • 1\. Significant concomitant medical conditions, defined as but not limited to:
  • a Historical/current evidence of clinically significant uncontrolled disease of
  • any body system. Significant is defined as any disease that, in the opinion of
  • investigator, would put safety of subject at risk through study
  • participation or which would confound the interpretation of study results if
  • disease/condition exacerbated during study.
  • b severe physical obstruction of the nose/nasal septal perforation that could
  • affect deposition of double blind intranasal study drug
  • c nasal/throat injury or surgery in last 3 mths

Outcomes

Primary Outcomes

Not specified

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