Study of ONO-1078 in Patients With Chronic Sinusitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00410735
First received: December 12, 2006
Last updated: June 12, 2012
Last verified: June 2012

December 12, 2006
June 12, 2012
December 2006
June 2008   (final data collection date for primary outcome measure)
  • nasal congestion [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • rhinorrhea [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • postnasal drip [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • easiness of removing postnasal drip [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • dull headache [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
15 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00410735
ONO-1078-37
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