Study of ONO-1078 in Patients With Chronic Sinusitis
This study has been completed.
Sponsor:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00410735
First received: December 12, 2006
Last updated: June 12, 2012
Last verified: June 2012
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Ono Pharmaceutical Co. Ltd:
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 |
|---|---|
| Placebo Comparator: P |
Drug: Placebo
0 mg BID for 12 weeks
|
| Experimental: E |
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 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Ono Pharmaceutical Co. Ltd |
| ClinicalTrials.gov Identifier: | NCT00410735 History of Changes |
| Other Study ID Numbers: | ONO-1078-37 |
| Study First Received: | December 12, 2006 |
| Last Updated: | June 12, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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 Therapeutic Uses Pharmacologic Actions Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013