Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00851344
First received: February 24, 2009
Last updated: June 18, 2009
Last verified: June 2009

February 24, 2009
June 18, 2009
September 2008
November 2008   (final data collection date for primary outcome measure)
Change from baseline in total nasal symptom score 0-4 hours post dose [ Time Frame: 0-4 hours post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00851344 on ClinicalTrials.gov Archive Site
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Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo
A Randomised, Double-Blind, Placebo-Controlled, 4-Period Incomplete Block Crossover Study of Single Oral Dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and Placebo to Evaluate the Efficacy and Safety Using an Environmental Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis

A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Allergic Rhinitis
  • Drug: GSK835726 (100mg)
    GSK835726 (100mg) tablet
  • Drug: Cetirizine (10mg)
    Cetirizine (10mg) tablet as positive control
  • Drug: GSK835726 (10mg)
    GSK835726 (10mg) tablet
  • Drug: GSK835726 (50mg)
    GSK835726 (50mg) tablet
  • Other: Placebo
    Placebo to match active
  • Active Comparator: Cetirizine 10mg
    10mg cetirizine as active comparator
    Intervention: Drug: Cetirizine (10mg)
  • Placebo Comparator: placebo
    placebo tablet
    Intervention: Other: Placebo
  • Active Comparator: GSK835726 (10mg)
    10mg oral dose
    Intervention: Drug: GSK835726 (10mg)
  • Active Comparator: GSK835726 (50mg)
    50mg oral dose
    Intervention: Drug: GSK835726 (50mg)
  • Active Comparator: GSK835726 (100mg)
    50mg oral dose
    Intervention: Drug: GSK835726 (100mg)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
  • Male
  • Aged 18 - 60
  • Weight 50kg+, BMI 19-32 kg/m2
  • Exhibit response to Challenge Chamber and skin prick test.
  • Non-smoker
  • Capable of giving informed consent

Exclusion Criteria:

  • No nasal structural abnornmality/polyposis, surgery, infection.
  • any respiratory disease, other than mild asthma or seasonal allergic rhinitis
  • participated in another clinical study within 30 days.
  • Subject has donated a unit of blood within 1 month
  • Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
  • History of sensitivty to drug
  • History of alcohol/drug abuse within 12 months.
  • Positive Hepatitis B antibody test
  • Positive HIV antibody test
  • Risk of non-compliance with study protocol
  • Perenial allergic rhinitis
  • Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
  • Past or present disease that may affect outcome, as judge by investigator
  • Specific Immunotherapy within 2 years
Male
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00851344
110163, 726 PoC
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2009

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