NCT00410735

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
495

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

1.5 years

First QC Date

December 12, 2006

Last Update Submit

June 12, 2012

Conditions

Chronic Sinusitis

Keywords

ONO-1078chronic sinusitis

Outcome Measures

Primary Outcomes (3)

  • nasal congestion

    12 weeks

  • rhinorrhea

    12 weeks

  • postnasal drip

    12 weeks

Secondary Outcomes (3)

  • easiness of blowing nose

    12 weeks

  • easiness of removing postnasal drip

    12 weeks

  • dull headache

    12 weeks

Study Arms (2)

P

PLACEBO COMPARATOR
Drug: Placebo

E

EXPERIMENTAL
Drug: Pranlukast hydrate

Interventions

PlaceboDRUG

0 mg BID for 12 weeks

P
Pranlukast hydrateDRUG

225 mg BID for 12 weeks

E

Eligibility Criteria

Age15 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • chronic sinusitis

You may not qualify if:

  • acute sinusitis
  • chronic sinusitis with acute exacerbation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chubu region

Chūbu, Japan

Location

Hokuriku region

Hokuriku, Japan

Location

Kanto region

Kanto, Japan

Location

Kinki region

Kinki, Japan

Location

Kyushu region

Kyushu, Japan

Location

Tohoku region

Tōhoku, Japan

Location

Study Officials

  • Hajime Yamamotoya

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2006

First Posted

December 13, 2006

Study Start

December 1, 2006

Primary Completion

June 1, 2008

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

JP(6)