Study of ONO-1078 in Patients With Chronic Sinusitis

NCT ID: NCT00410735

Last Updated: 2012-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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P

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0 mg BID for 12 weeks

E

Group Type EXPERIMENTAL

Pranlukast hydrate

Intervention Type DRUG

225 mg BID for 12 weeks

Interventions

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Placebo

0 mg BID for 12 weeks

Intervention Type DRUG

Pranlukast hydrate

225 mg BID for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* chronic sinusitis

Exclusion Criteria

* acute sinusitis
* chronic sinusitis with acute exacerbation
Minimum Eligible Age

15 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hajime Yamamotoya

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Chubu region

Chūbu, , Japan

Site Status

Hokuriku region

Hokuriku, , Japan

Site Status

Kanto region

Kanto, , Japan

Site Status

Kinki region

Kinki, , Japan

Site Status

Kyushu region

Kyushu, , Japan

Site Status

Tohoku region

Tōhoku, , Japan

Site Status

Countries

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Japan

Other Identifiers

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ONO-1078-37

Identifier Type: -

Identifier Source: org_study_id

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