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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000040561 |
Receipt No. | R000046296 |
Scientific Title | Efficacy and safety of omalizumab, an anti-IgE monoclonal antibody, in patients with seasonal allergic rhinitis: a systematic review. |
Date of disclosure of the study information | 2020/06/01 |
Last modified on | 2020/06/07 |
Basic information | ||
Public title | Efficacy and safety of omalizumab, an anti-IgE monoclonal antibody, in patients with seasonal allergic rhinitis: a systematic review. | |
Acronym | omalizumab for seasonal allergic rhinitis | |
Scientific Title | Efficacy and safety of omalizumab, an anti-IgE monoclonal antibody, in patients with seasonal allergic rhinitis: a systematic review. | |
Scientific Title:Acronym | omalizumab for seasonal allergic rhinitis | |
Region |
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Condition | ||
Condition | seasonal allergic rhinitis | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To assess the efficacy and safety of omalizumab for seasonal allergic rhinitis |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | daily nasal symptom score
any adverse events |
Key secondary outcomes |
Base | |
Study type | Others,meta-analysis etc |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | A randomized controlled trial evaluating the efficacy and safety of omalizumab in patients with controlled seasonal allergic rhinitis.
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Key exclusion criteria | Case reports, case-control studies, cohort studies, and single-arm studies. | |||
Target sample size |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Showa University School of Medicine
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Division name | Department of Medicine, Division of Respiratory Medicine and Allergology, | ||||||
Zip code | 142-8666 | ||||||
Address | 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan | ||||||
TEL | +81-3-37848532 | ||||||
koichi-a@med.showa-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Showa University School of Medicine | ||||||
Division name | Department of Medicine, Division of Respiratory Medicine and Allergology, | ||||||
Zip code | 140-8666 | ||||||
Address | 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan | ||||||
TEL | +81-3-37848532 | ||||||
Homepage URL | |||||||
koichi-a@med.showa-u.ac.jp |
Sponsor | |
Institute | Showa University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Showa University School of Medicine |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Showa University School of Medicine |
Address | 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan |
Tel | +81-3-37848532 |
koichi-a@med.showa-u.ac.jp |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 2270 |
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 |
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Date of IRB |
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Date analysis concluded |
Other | |
Other related information | Statistical heterogeneity between studies will be assessed using the I2 statistic. This is an indicator of the degree of heterogeneity of the outcome measures, with values above 50% indicating significant heterogeneity. We adopt a random-effects model with or without statistically significant heterogeneity. Effect size assesses the difference in efficacy and safety outcomes between the omalizumab and control groups and is expressed as the mean difference (MD), risk ratio (RR), and 95% confidence interval (CI). Subgroup analysis is performed by antigens causing seasonal allergic rhinitis. Statistical analysis of publication bias is done using Egger's and Peters test. All P values are bilateral, with P < 0.05 being significant. All analyses are performed using RevMan (version 5.3; Cochrane Corporation, Oxford, UK) and STATA (version 14.0; Stata Corp., College Station, TX, USA). |
Management information | |||||||
Registered date |
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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=R000046296 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |