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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008633
Receipt No. R000010142
Scientific Title A Phase 4 clinical trial of EMPYNASE P tablets 18000 in patients with chronic sinusitis
Date of disclosure of the study information 2012/08/06
Last modified on 2014/05/08

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Basic information
Public title A Phase 4 clinical trial of EMPYNASE P tablets 18000 in patients with chronic sinusitis
Acronym A Phase 4 clinical trial of EMPYNASE P tablets 18000 in patients with chronic sinusitis
Scientific Title A Phase 4 clinical trial of EMPYNASE P tablets 18000 in patients with chronic sinusitis
Scientific Title:Acronym A Phase 4 clinical trial of EMPYNASE P tablets 18000 in patients with chronic sinusitis
Region
Japan

Condition
Condition chronic sinusitis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of EMPYNASE P tablets 18000 to placebo for patients with chronic sinusitis in combination with macrolide therapy as standard therapy for 12 weeks by double-blind, Parallel Group comparative study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes -Change in total score of both nasal sides based on scoring of disease state in maxillary sinuses by conventional radiography
Key secondary outcomes -Change in total score of both nasal sides based on scoring of objective opinion on nasal cavity

-Change of score based on scoring of subjective nasal symptom

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 EMPYNASE group
EMPYNASE P Tablets are administrated orally after three meals for 12 weeks.
Clarithromycin Tablets are administrated orally after breakfast for 14 weeks.
Interventions/Control_2 Placebo group
Placebo Tablets are administrated orally after three meals for 12 weeks.
Clarithromycin Tablets are administrated orally after breakfast for 14 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Written informed consent obtained from patients
-Patients over 20 years old
-Patients with symptoms which had persisted for more than or equal to 12 weeks, such as nasal congestion, rhinorrhea, postnasal drip and coughing
-Patients with certain score of both sides based on scoring of disease state in maxillary sinuses by conventional radiography
-Patients with certain score of both sides based on scoring of edema and swelling of nasal mucosa
-Patients with certain score based on scoring of rhinorrhea or postnasal drip
Key exclusion criteria -Patients with nasal polyp of score 2 or 3
-Patients diagnosed as eosinophilic sinusitis by the principal investigator or sub-investigator
-Patients with complication such as maxillary sinusitis of dental origin, caseous maxillary sinusitis, sinus syst or asthma including aspirin-induced asthma
-Patients with symptoms of acute sinusitis or acute exacerbation
-Patients with pollinosis ( seasonal allergic rhinitis ), and term of causative pollen dispersal
-Patients who have or are suspected to have sinus mycosis
-Patients who have undergone operation of maxillary sinus, endoscopic sinus surgery or nasal polyplectomy, however patients underwent nasal polyplectomy before 3 months or more are excepted
-Patients treated with the prohibited medication or therapy within 2 weeks
Target sample size 260

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chikara Ieda
Organization Kaken Pharmaceutical Co., LTD.
Division name Clinical Development Department
Zip code
Address 28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
TEL 03-5977-5111
Email ieda_chikara@kaken.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Urabe
Organization KAKEN PHARMACEUTICAL CO., LTD.
Division name Clinical Development Department
Zip code
Address 28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, Japan
TEL 03-5977-5111
Homepage URL
Email urabe_yoshitaka@kaken.co.jp

Sponsor
Institute KAKEN PHARMACEUTICAL CO., LTD.
Institute
Department

Funding Source
Organization KAKEN PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 20 Day
Last follow-up date
2014 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 08 Month 06 Day
Last modified on
2014 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010142

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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