Study of ONO-1078 in Patients With Chronic Sinusitis

Phase 3

Completed

• Conditions: Chronic Sinusitis
• Interventions: Drug: Pranlukast hydrate; Drug: Placebo

• Registration Number: NCT00410735
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-12
• Study First Submitted QC: 2006-12-12
• Study First Posted: 2006-12-13
• Primary Completion: 2008-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 495

Inclusion Criteria

• chronic sinusitis

Exclusion Criteria

• acute sinusitis
• chronic sinusitis with acute exacerbation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E	Pranlukast hydrate	-
P	Placebo	-

Primary Outcome Measures

Name	Time	Method
nasal congestion	12 weeks
rhinorrhea	12 weeks
postnasal drip	12 weeks

Secondary Outcome Measures

Name	Time	Method
easiness of blowing nose	12 weeks
easiness of removing postnasal drip	12 weeks
dull headache	12 weeks

Trial Locations

Locations (6)

Chubu region; 🇯🇵 Chubu, Japan

Hokuriku region; 🇯🇵 Hokuriku, Japan

Kanto region; 🇯🇵 Kanto, Japan

Tohoku region; 🇯🇵 Tohoku, Japan

Kinki region; 🇯🇵 Kinki, Japan

Kyushu region; 🇯🇵 Kyushu, Japan