UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005985 |
|---|---|
| Receipt number | 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 14:36:07 |
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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
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
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007081
