UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008633 |
|---|---|
| Receipt number | 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 13:53:20 |
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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
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
urabe_yoshitaka@kaken.co.jp
Sponsor or person
Institute
KAKEN PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010142
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