Unique ID issued by UMIN | UMIN000000709 |
---|---|
Receipt number | R000000845 |
Scientific Title | Clinical efficacy and safety of sublingual immunotherapy in patients with Japanese cedar pollinosis.A double-blind,placebo-controlled study. |
Date of disclosure of the study information | 2007/05/07 |
Last modified on | 2012/01/26 16:40:55 |
Clinical efficacy and safety of sublingual immunotherapy in patients with Japanese cedar pollinosis.A double-blind,placebo-controlled study.
Clinical efficacy and safety of SLIT in patients with Japanese cedar pollinosis.
Clinical efficacy and safety of sublingual immunotherapy in patients with Japanese cedar pollinosis.A double-blind,placebo-controlled study.
Clinical efficacy and safety of SLIT in patients with Japanese cedar pollinosis.
Japan |
Japanese cedar pollinosis
Oto-rhino-laryngology |
Others
NO
The purpose of this study is to evaluate the efficacy and safety of Sublingual Immunotherapy for Japanese cedar pollinosis by multicenter,prospective,randomaized,placebocontrolled trial.
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
Symptom-medication score
1)Adverse event
2)Evaluation of biomarker
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
From September 2006 to May 2008,patients of control 1 receive active treatment once weekly.The induction/build-up phase is 3 weeks,with an increasing daliy number of the extract drops at three consentrations.
From September 2006 to May 2008,patients of control 2 receive placebo once weekly.The induction/build-up phase is 3 weeks,with an increasing daliy number of the placebo drops as control 1.
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1)Clinical history of cedar pollen-induced allergic rhinoconjunctivitis for at least 3 years
2)Positive specific IgE to cry j1/2 antigen(CAP-RAST>=class2)
1)The history of severe asthma
2)The history of anti-allergic drugs within 4 weeks
3)Perior history of immunotherapy with cedar pollen
4)Pregnant women and those at risk of pregnancy
5)Complication of the other nasal-paranasal disease
150
1st name | |
Middle name | |
Last name | Yoshitaka Okamoto |
Chiba University Graduate School
Department of Otorhinolaryngology
1-8-1 Inohana,Chuo-ku Chiba 260-8677
043-22-7171
1st name | |
Middle name | |
Last name | Shigetoshi Horiguchi |
Chiba University Graduate School
Department of Otorhinolaryngology
1-8-1 Inohana,Chuo-ku Chiba 260-8677
043-22-7171
Department of Otorhinolaryngology in Ciba University Graduate School
Ministry of Health, Labour and Welfare
NO
2007 | Year | 05 | Month | 07 | Day |
Published
Completed
2006 | Year | 09 | Month | 01 | Day |
2006 | Year | 09 | Month | 01 | Day |
2008 | Year | 05 | Month | 01 | Day |
2007 | Year | 05 | Month | 07 | Day |
2012 | Year | 01 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000845