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
  Purpose

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


Condition Intervention Phase
Chronic Sinusitis
Drug: Placebo
Drug: Pranlukast hydrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of ONO-1078 in Patients With Chronic Sinusitis, a Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 495
Study Start Date: December 2006
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: P Drug: Placebo
0 mg BID for 12 weeks
Experimental: E Drug: Pranlukast hydrate
225 mg BID for 12 weeks

  Eligibility

Ages Eligible for Study:   15 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic sinusitis

Exclusion Criteria:

  • acute sinusitis
  • chronic sinusitis with acute exacerbation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410735

Locations
Japan
Chubu region
Chubu, Japan
Hokuriku region
Hokuriku, Japan
Kanto region
Kanto, Japan
Kinki region
Kinki, Japan
Kyushu region
Kyushu, Japan
Tohoku region
Tohoku, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Hajime Yamamotoya Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00410735     History of Changes
Other Study ID Numbers: ONO-1078-37
Study First Received: December 12, 2006
Last Updated: June 12, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-1078
chronic sinusitis

Additional relevant MeSH terms:
Chronic Disease
Sinusitis
Disease Attributes
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 23, 2014