Study of ONO-1078 in Patients With Chronic Sinusitis - Full Text View

Sponsored by:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00410735

Purpose

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

Condition	Intervention	Phase
Chronic Sinusitis	Drug: Placebo Drug: Pranlukast hydrate	Phase III

MedlinePlus related topics: Sinusitis

Drug Information available for: Pranlukast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study of ONO-1078 in Patients With Chronic Sinusitis, a Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study

Further study details as provided by Ono Pharma:

Primary Outcome Measures:

nasal congestion [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
rhinorrhea [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
postnasal drip [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

easiness of blowing nose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
easiness of removing postnasal drip [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
dull headache [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	495
Study Start Date:	December 2006
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
P: Placebo Comparator	Drug: Placebo 0 mg BID for 12 weeks
E: Experimental	Drug: Pranlukast hydrate 225 mg BID for 12 weeks

Eligibility

Ages Eligible for Study:	15 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

chronic sinusitis

Exclusion Criteria:

acute sinusitis
chronic sinusitis with acute exacerbation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410735

Locations

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

Sponsors and Collaborators

Ono Pharma

Investigators

Study Director:

Hajime Yamamotoya

Ono Pharma

More Information

No publications provided

Responsible Party:	Development Headquarters, ONO Pharmaceutical Co., Ltd ( Hiroshi Awata, Executive Director, Development Headquarters )
Study ID Numbers:	ONO-1078-37
Study First Received:	December 12, 2006
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00410735 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharma:

ONO-1078
chronic sinusitis

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents

Pranlukast
Chronic Disease
Sinusitis
Hormones
Leukotriene Antagonists

Additional relevant MeSH terms:

Respiratory System Agents
Disease Attributes
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pranlukast

Sinusitis
Pharmacologic Actions
Nose Diseases
Leukotriene Antagonists
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Chronic Disease

ClinicalTrials.gov processed this record on May 06, 2009