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

Sponsors

Lead Sponsor: Ono Pharmaceutical Co. Ltd

Source Ono Pharmaceutical Co. Ltd
Brief 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

Overall Status Completed
Start Date 2006-12-01
Primary Completion Date 2008-06-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
nasal congestion 12 weeks
rhinorrhea 12 weeks
postnasal drip 12 weeks
Secondary Outcome
Measure Time Frame
easiness of blowing nose 12 weeks
easiness of removing postnasal drip 12 weeks
dull headache 12 weeks
Enrollment 495
Condition
Intervention

Intervention Type: Drug

Intervention Name: Placebo

Description: 0 mg BID for 12 weeks

Arm Group Label: P

Intervention Type: Drug

Intervention Name: Pranlukast hydrate

Description: 225 mg BID for 12 weeks

Arm Group Label: E

Eligibility

Criteria:

Inclusion Criteria: - chronic sinusitis Exclusion Criteria: - acute sinusitis - chronic sinusitis with acute exacerbation

Gender:

All

Minimum Age:

15 Years

Maximum Age:

74 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Hajime Yamamotoya Study Director Ono Pharmaceutical Co. Ltd
Location
Facility:
Chubu region | Chubu, Japan
Hokuriku region | Hokuriku, Japan
Kanto region | Kanto, Japan
Kinki region | Kinki, Japan
Kyushu region | Kyushu, Japan
Tohoku region | Tohoku, Japan
Location Countries

Japan

Verification Date

2012-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: P

Type: Placebo Comparator

Label: E

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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