Study of ONO-1078 in Patients With Chronic Sinusitis

Chronic Sinusitis Clinical Trial

Official title:

Study of ONO-1078 in Patients With Chronic Sinusitis, a Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00410735
• Other study ID #: ONO-1078-37
• Status: Completed
• Phase: Phase 3
• First received: December 12, 2006
• Last updated: June 12, 2012
• Start date: December 2006

Study information

• Verified date: June 2012
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 74 Years

Eligibility

Inclusion Criteria:

• chronic sinusitis

Exclusion Criteria:

• acute sinusitis

• chronic sinusitis with acute exacerbation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Intervention

Drug:
• Placebo
0 mg BID for 12 weeks
• Pranlukast hydrate
225 mg BID for 12 weeks

Locations

Country	Name	City	State
Japan	Chubu region	Chubu
Japan	Hokuriku region	Hokuriku
Japan	Kanto region	Kanto
Japan	Kinki region	Kinki
Japan	Kyushu region	Kyushu
Japan	Tohoku region	Tohoku

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nasal congestion		12 weeks	No
Primary	rhinorrhea		12 weeks	No
Primary	postnasal drip		12 weeks	No
Secondary	easiness of blowing nose		12 weeks	No
Secondary	easiness of removing postnasal drip		12 weeks	No
Secondary	dull headache		12 weeks	No