search
Back to results

Study of ONO-1078 in Patients With Chronic Sinusitis

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Placebo
Pranlukast hydrate
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis focused on measuring ONO-1078, chronic sinusitis

Eligibility Criteria

15 Years - 74 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic sinusitis

Exclusion Criteria:

  • acute sinusitis
  • chronic sinusitis with acute exacerbation

Sites / Locations

  • Chubu region
  • Hokuriku region
  • Kanto region
  • Kinki region
  • Kyushu region
  • Tohoku region

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

P

E

Arm Description

Outcomes

Primary Outcome Measures

nasal congestion
rhinorrhea
postnasal drip

Secondary Outcome Measures

easiness of blowing nose
easiness of removing postnasal drip
dull headache

Full Information

First Posted
December 12, 2006
Last Updated
June 12, 2012
Sponsor
Ono Pharmaceutical Co. Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT00410735
Brief Title
Study of ONO-1078 in Patients With Chronic Sinusitis
Official Title
Study of ONO-1078 in Patients With Chronic Sinusitis, a Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
Keywords
ONO-1078, chronic sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
495 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P
Arm Type
Placebo Comparator
Arm Title
E
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0 mg BID for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Pranlukast hydrate
Intervention Description
225 mg BID for 12 weeks
Primary Outcome Measure Information:
Title
nasal congestion
Time Frame
12 weeks
Title
rhinorrhea
Time Frame
12 weeks
Title
postnasal drip
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
easiness of blowing nose
Time Frame
12 weeks
Title
easiness of removing postnasal drip
Time Frame
12 weeks
Title
dull headache
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic sinusitis Exclusion Criteria: acute sinusitis chronic sinusitis with acute exacerbation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hajime Yamamotoya
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Chubu region
City
Chubu
Country
Japan
Facility Name
Hokuriku region
City
Hokuriku
Country
Japan
Facility Name
Kanto region
City
Kanto
Country
Japan
Facility Name
Kinki region
City
Kinki
Country
Japan
Facility Name
Kyushu region
City
Kyushu
Country
Japan
Facility Name
Tohoku region
City
Tohoku
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Study of ONO-1078 in Patients With Chronic Sinusitis

We'll reach out to this number within 24 hrs