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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00410735
Enrollment
495
Registered
2006-12-13
Start date
2006-12-31
Completion date
Unknown
Last updated
2012-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Sinusitis

Keywords

ONO-1078, chronic sinusitis

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

Interventions

DRUGPlacebo

0 mg BID for 12 weeks

DRUGPranlukast hydrate

225 mg BID for 12 weeks

Sponsors

Ono Pharmaceutical Co. Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
15 Years to 74 Years
Healthy volunteers
No

Inclusion criteria

* chronic sinusitis

Exclusion criteria

* acute sinusitis * chronic sinusitis with acute exacerbation

Design outcomes

Primary

MeasureTime frame
nasal congestion12 weeks
rhinorrhea12 weeks
postnasal drip12 weeks

Secondary

MeasureTime frame
easiness of blowing nose12 weeks
easiness of removing postnasal drip12 weeks
dull headache12 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026