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Study of ONO-1078 in Patients With Chronic Sinusitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00410735
First Posted: December 13, 2006
Last Update Posted: June 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
December 12, 2006
December 13, 2006
June 13, 2012
December 2006
June 2008   (Final data collection date for primary outcome measure)
  • nasal congestion [ Time Frame: 12 weeks ]
  • rhinorrhea [ Time Frame: 12 weeks ]
  • postnasal drip [ Time Frame: 12 weeks ]
  • nasal congestion
  • rhinorrhea
  • postnasal drip
Complete list of historical versions of study NCT00410735 on ClinicalTrials.gov Archive Site
  • easiness of blowing nose [ Time Frame: 12 weeks ]
  • easiness of removing postnasal drip [ Time Frame: 12 weeks ]
  • dull headache [ Time Frame: 12 weeks ]
  • easiness of blowing nose
  • easiness of removing postnasal drip
  • dull headache
Not Provided
Not Provided
 
Study of ONO-1078 in Patients With Chronic Sinusitis
Study of ONO-1078 in Patients With Chronic Sinusitis, a Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study
To determine the efficacy and safety of ONO-1078 in patients with chronic sinusitis in a double-blind, randomized, placebo-controlled, parallel group, multi-center study
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Chronic Sinusitis
  • Drug: Placebo
    0 mg BID for 12 weeks
  • Drug: Pranlukast hydrate
    225 mg BID for 12 weeks
  • Placebo Comparator: P
    Intervention: Drug: Placebo
  • Experimental: E
    Intervention: Drug: Pranlukast hydrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
495
Not Provided
June 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • chronic sinusitis

Exclusion Criteria:

  • acute sinusitis
  • chronic sinusitis with acute exacerbation
Sexes Eligible for Study: All
15 Years to 74 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00410735
ONO-1078-37
Not Provided
Not Provided
Not Provided
Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
Not Provided
Study Director: Hajime Yamamotoya Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
June 2012

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