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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005985
Receipt No. R000007081
Scientific Title A Randomized Placebo-controlled Trial of an Early Interventional Treatment with Mometasone Furoate Nasal Spray in Japanese Cedar/Cypress Pollinosis
Date of disclosure of the study information 2011/07/16
Last modified on 2013/02/11

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Basic information
Public title A Randomized Placebo-controlled Trial of an Early Interventional Treatment with Mometasone Furoate Nasal Spray in Japanese Cedar/Cypress Pollinosis
Acronym Effect of EIT with mometasone on JCCP
Scientific Title A Randomized Placebo-controlled Trial of an Early Interventional Treatment with Mometasone Furoate Nasal Spray in Japanese Cedar/Cypress Pollinosis
Scientific Title:Acronym Effect of EIT with mometasone on JCCP
Region
Japan

Condition
Condition Japanese cedar/cypress pollinosis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the efficacy and safety of early interventional treatment with mometasone furoate in Japanese cedar/cypress pollinosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of total nasal symptom score (TNSS) between active and placebo group
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In February 1st, 2010, patients begin to receive mometasone self-administered two sprays in each nostril once daily in the morning (total dose of MF 200 ug). This treatment is continued until the end of April for 12 weeks.
Interventions/Control_2 In February 1st, 2010, patients begin to receive placebo self-administered two sprays in each nostril once daily in the morning. This treatment is continued until the end of April for 12 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
16 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria (a) at least two year history of JCCP, (b) sensitization to Japanese cedar pollen assessed by skin prick test, (c) ability to fill in the diary cards accurately.
Key exclusion criteria (a) concomitant sinonasal disease affecting the outcomes of this trial (e.g. nasal polyps, rhinosinusitis, nasal septum deviation); (b) concomitant treatment-requiring allergic rhinitis caused by allergens other than Japanese cedar/cypress pollen; (c) rhinitis medicamentosa and non-infectious, non-allergic rhinitis; (d) cedar pollen-specific immunotherapy; (e) sinonasal surgery including laser vaporization of inferior turbinates within 1 year; (f) medication with anti-allergic drugs including antihistamines, chromons, glucocorticoids and decongentants within 2 weeks; (g) hypersensitivity to MFNS; (h) systemic infection including mycosis; (i) pregnancy and breastfeeding.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Okano
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Otolaryngology-Head & Neck Surgery
Zip code
Address 2-5-1 Shikatacho, Okayama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Otolaryngology-Head & Neck Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Self Funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2011 Year 07 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2010 Year 05 Month 01 Day
Date of closure to data entry
2010 Year 09 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 15 Day
Last modified on
2013 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007081

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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