Study of ONO-1078 in Patients With Chronic Sinusitis
NCT00410735 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 495
Last updated 2012-06-13
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
Conditions
- Chronic Sinusitis
Interventions
- DRUG
-
0 mg BID for 12 weeks
- DRUG
-
Pranlukast hydrate
225 mg BID for 12 weeks
Sponsors & Collaborators
-
Ono Pharmaceutical Co. Ltd
lead INDUSTRY
Principal Investigators
-
Hajime Yamamotoya · Ono Pharmaceutical Co. Ltd
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 74 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-12-31
- Primary Completion
- 2008-06-30
Countries
- Japan
Study Locations
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