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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000001644 |
Receipt No. | R000001976 |
Scientific Title | A comparison of regular and as-needed use of Mometasone furoate hydrate nasal spray in the treatment of Japanese cedar pollinosis |
Date of disclosure of the study information | 2009/01/17 |
Last modified on | 2016/02/29 |
Basic information | ||
Public title | A comparison of regular and as-needed use of Mometasone furoate hydrate nasal spray in the treatment of Japanese cedar pollinosis | |
Acronym | Mometasone furoate hydrate nasal spray for pollinosis: regular versus as-needed use | |
Scientific Title | A comparison of regular and as-needed use of Mometasone furoate hydrate nasal spray in the treatment of Japanese cedar pollinosis | |
Scientific Title:Acronym | Mometasone furoate hydrate nasal spray for pollinosis: regular versus as-needed use | |
Region |
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Condition | ||
Condition | Japanese cedar pollinosis | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the effectiveness of regular and as-needed use of Mometasone furoate hydrate nasal spray for Japanese cedar pollinosis with the disease specific quality of life questionnaire. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase |
Assessment | |
Primary outcomes | Overall quality of life score of Rhinoconjunctivitis Quality of Life Questionnire. |
Key secondary outcomes | 1) Each score of seven domains of RQLQ.
2) Two summary scores (PCS and MCS) of SF-36 v2. 3) Each severity score of four daily nasal symptoms (runny nose, itchy nose , stuffy nose, and sneezing). 4) Total nasal symptom score (the sum of four nasal symptom scores). 5) Each severity score of three daily ocular symptoms (eye itchiness, eye redness, and tearing). 6) Total ocular symptom score (the sum of three ocular symptom scores). |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | Institution is considered as a block. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Regular use group: Taking two puffs of Mometasone furoate hydrate nasal spray into each nostril (total 200 ug/day) every morning from the onset of nasal symptoms. | |
Interventions/Control_2 | As-needed use group: Taking two puffs of Mometasone furoate hydrate nasal spray into each nostril once a day (total 200 ug/day) in case of the patient having troublesome nasal symptoms. | |
Interventions/Control_3 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) A history of Japanese cedar pollinosis for at least one season before study entry.
2) Positive allergy skin test to Japanese cedar pollen or Japanese cedar pollen specific IgE RAST score >= class 2. 3) Written informed consent is required. |
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Key exclusion criteria | 1) Taking any immunosuppressive drugs or systemic steroid drugs within six months before study entry.
2) Taking any antibiotics within two weeks before study entry. 3) Taking any anti-allergy drugs within two weeks before study entry. 4) Using any anti-allergy nasal drops within two weeks before study entry. 5) Under treatment of buildup phase of specific immunotherapy. 6) Patients with deflected nasal septum, sinusitis, or nasal polyps which cause a barrier to evaluate nasal symptoms. 7) Patients with upper respiratory inflammation, respiratory infection, or severe bronchial asthma. 8) Patients with severe cardiac, hepatic, kidney, or hematological disease. 9) A history of hypersensitivity to mometasone furoate hydrate, loratadine, or sodium cromoglycate. 10) Pregnant or lactating women and women who may be pregnant. 11) Taking a drug of erythromycin or cimetidine. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | University of Yamanashi | ||||||
Division name | Department of Otorhinolaryngology, Head & Neck Surgery | ||||||
Zip code | |||||||
Address | 1110 Shimokato, Chuo-shi, Yamanashi-ken, JAPAN | ||||||
TEL | 055-273-6769 | ||||||
mkeisuke@yamanashi.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | University of Yamanashi | ||||||
Division name | Department of Otorhinolaryngology, Head & Neck Surgery | ||||||
Zip code | |||||||
Address | 1110 Shimokato, Chuo-shi, Yamanashi-ken, JAPAN | ||||||
TEL | 055-273-6769 | ||||||
Homepage URL | http://www.yuent.umin.jp/kafun/ | ||||||
tgoro@yamanashi.ac.jp |
Sponsor | |
Institute | Department of Otorhinolaryngology, Head & Neck Surgery, Faculty of Medicine, University of Yamanashi |
Institute | |
Department |
Funding Source | |
Organization | self funding |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | None |
Name of secondary funder(s) | None |
IRB Contact (For public release) | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001976 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |