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Study of ONO-1078 in Patients With Chronic Sinusitis

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ClinicalTrials.gov Identifier: NCT00410735
Recruitment Status : Completed
First Posted : December 13, 2006
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Drug: Placebo Drug: Pranlukast hydrate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 495 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of ONO-1078 in Patients With Chronic Sinusitis, a Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study
Study Start Date : December 2006
Actual Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: P Drug: Placebo
0 mg BID for 12 weeks
Experimental: E Drug: Pranlukast hydrate
225 mg BID for 12 weeks



Primary Outcome Measures :
  1. nasal congestion [ Time Frame: 12 weeks ]
  2. rhinorrhea [ Time Frame: 12 weeks ]
  3. postnasal drip [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. easiness of blowing nose [ Time Frame: 12 weeks ]
  2. easiness of removing postnasal drip [ Time Frame: 12 weeks ]
  3. dull headache [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 74 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic sinusitis

Exclusion Criteria:

  • acute sinusitis
  • chronic sinusitis with acute exacerbation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410735


Locations
Japan
Chubu region
Chubu, Japan
Hokuriku region
Hokuriku, Japan
Kanto region
Kanto, Japan
Kinki region
Kinki, Japan
Kyushu region
Kyushu, Japan
Tohoku region
Tohoku, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Hajime Yamamotoya Ono Pharmaceutical Co. Ltd

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00410735     History of Changes
Other Study ID Numbers: ONO-1078-37
First Posted: December 13, 2006    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-1078
chronic sinusitis

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Pranlukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs