Study of ONO-1078 in Patients With Chronic Sinusitis

Ono Pharmaceutical Co., Ltd.495 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

495

Conditions

Chronic Sinusitis

Interventions

PlaceboDRUG

0 mg BID for 12 weeks

Pranlukast hydrateDRUG

225 mg BID for 12 weeks

Eligibility

Sex: ALLMin age: 15 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (6)

Chubu region

Chūbu, Japan

Hokuriku region

Hokuriku, Japan

Kanto region

Kanto, Japan

Kinki region

Kinki, Japan

Kyushu region

Kyushu, Japan

Outcomes

Primary Outcomes

nasal congestion

Time frame: 12 weeks

rhinorrhea

Time frame: 12 weeks

postnasal drip

Time frame: 12 weeks

Secondary Outcomes

easiness of blowing nose

Time frame: 12 weeks

easiness of removing postnasal drip

Time frame: 12 weeks

dull headache

Time frame: 12 weeks

Data from ClinicalTrials.gov

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