Study of ONO-1078 in Patients With Chronic Sinusitis

Study of ONO-1078 in Patients With Chronic Sinusitis, a Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study

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 Overview

• Status: Completed
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Drug: Placebo; Drug: Pranlukast hydrate

• Study Type: Interventional
• Enrollment (Actual): 495
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chubu, Japan
    • Chubu Region
  • Hokuriku, Japan
    • Hokuriku region
  • Kanto, Japan
    • Kanto region
  • Kinki, Japan
    • Kinki region
  • Kyushu, Japan
    • Kyushu region
  • Tohoku, Japan
    • Tohoku region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 74 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• chronic sinusitis

Exclusion Criteria:

• acute sinusitis
• chronic sinusitis with acute exacerbation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: E	Drug: Pranlukast hydrate; 225 mg BID for 12 weeks
PLACEBO_COMPARATOR: P	Drug: Placebo; 0 mg BID for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
nasal congestion	12 weeks
rhinorrhea	12 weeks
postnasal drip	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
easiness of blowing nose	12 weeks
easiness of removing postnasal drip	12 weeks
dull headache	12 weeks

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Hajime Yamamotoya, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (ACTUAL): June 1, 2008

Study Registration Dates

• First Submitted: December 12, 2006
• First Submitted That Met QC Criteria: December 12, 2006
• First Posted (ESTIMATE): December 13, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): June 13, 2012
• Last Update Submitted That Met QC Criteria: June 12, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: chronic sinusitis; ONO-1078
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Chronic Disease; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Pranlukast
• Other Study ID Numbers: ONO-1078-37