更新于：2024-05-01
Betotastine besilate
苯磺贝他斯汀
更新于：2024-05-01
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构
分子式C21H25ClN2O3 |
InChIKeyYWGDOWXRIALTES-NRFANRHFSA-N |
CAS号125602-71-3 |
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关联
40
项与 苯磺贝他斯汀 相关的临床试验苯磺贝他斯汀片随机、开放、单次给药、两制剂、两周期、交叉健康人体生物等效性试验
苯磺贝他斯汀口崩片在健康受试者中餐后和空腹状态下的单剂量、随机、开放、两周期、自身交叉设计的生物等效性试验
PHASE IV, MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, CONTROLLED,60 DAYS, PARALLEL GROUPS, SUPERIORITY STUDY, TO COMPARE THE EFFECTIVENESS AND TOXICITY OF BEPOTASTINE 1.5% PF vs. OLOPATADINE 0.2% WITH BAK IN TREATMENT OF ALLERGIC CONJUNCTIVITIS
100 项与 苯磺贝他斯汀 相关的临床结果
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100 项与 苯磺贝他斯汀 相关的转化医学
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100 项与 苯磺贝他斯汀 相关的专利（医药）
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50
项与 苯磺贝他斯汀 相关的文献（医药）2024-02-22JMIR research protocols
The Efficacy of Bepotastine Besilate Compared With Hydroxyzine Pamoate for Preventing Infusion Reactions to the First Dose of Rituximab in Patients With Non-Hodgkin Lymphoma: Protocol for a Phase II, Double-Blind, Multicenter Randomized Trial.
Article
作者: Yumi Kitahiro ; Kazuhiro Yamamoto ; Kimikazu Yakushijin ; Takeshi Ioroi ; Masaaki Tanda ; Kotaro Itohara ; Tomohiro Omura ; Hironobu Minami ; Ikuko Yano
BACKGROUND:
Rituximab, an anti-CD20 monoclonal antibody, can cause infusion reactions (IRs), especially during the initial rituximab infusion therapy. Generally, patients are administered a histamine H1-receptor antagonist before the rituximab infusion, along with an antipyretic analgesic, to prevent or reduce IRs. Multiple retrospective case-control studies indicate that the second generation of histamine H1-receptor antagonists might be more effective than the first generation in suppressing IRs caused by the rituximab infusion.
OBJECTIVE:
This study aimed to assess the efficacy of first- and second-generation histamine H1-receptor antagonists for preventing IRs resulting from the initial infusion of rituximab in patients diagnosed with non-Hodgkin lymphoma.
METHODS:
This is a phase II, double-blind, active-controlled randomized trial. It will be a multicenter study conducted across 3 facilities that aims to enroll a total of 40 patients diagnosed with non-Hodgkin lymphoma who will receive their initial rituximab infusion. Participating patients will be administered hydroxyzine pamoate or bepotastine besilate, representing first- or second-generation histamine H1-receptor antagonists, respectively. This will be combined with 400-mg acetaminophen tablets taken approximately 30 minutes before the first infusion of rituximab. The primary end point of this trial is to assess severe IRs, equivalent to grade 2 or higher as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0, that occur within a 4-hour period after the initiation of rituximab infusion. The secondary end points include assessing the severity of the initial IR, the maximum severity of the IR, and the duration between rituximab infusion initiation and the onset of the first IR within a 4-hour period. Additionally, the trial will evaluate histamine H1-receptor antagonist-induced drowsiness using the visual analogue scale, with each patient providing their individual response.
RESULTS:
This study began with patient recruitment in April 2023, with 17 participants enrolled as of November 12, 2023. The anticipated study completion is set for February 2026.
CONCLUSIONS:
This study is the first randomized controlled trial comparing the effects of oral first- and second-generation histamine H1-receptor antagonists in preventing IRs induced by the initial administration of rituximab. The findings from this study hold the potential to establish the rationale for a phase III study aimed at determining the standard premedication protocol for rituximab infusion.
TRIAL REGISTRATION:
Japan Registry of Clinical Trials jRCTs051220169; https://jrct.niph.go.jp/latest-detail/jRCTs051220169.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):
DERR1-10.2196/54882.
2023-01-25Indian journal of dermatology, venereology and leprology
Comparative study on the efficacy and safety of bepotastine besilate versus levocetirizine in chronic spontaneous urticaria: A randomised, open-label, parallel study.
Article
作者: Elango Gayathri ; Parvathareddy Sowmya ; Kumaravelu Punnagai ; Veeraraghavan Mahalakshmi
Background Urticaria is a common skin disease which often causes impairment in the quality of life. The ideal drug for chronic urticaria would have antihistaminic and anti-inflammatory actions. Bepotastine besilate is a recently approved novel anti-allergic agent with multiple mechanisms of action; levocetirizine is a potent and selective second-generation H1 receptor antagonist used in the treatment of urticaria. Aim To compare the efficacy and safety of bepotastine besilate versus levocetirizine in patients with chronic spontaneous urticaria. Methods The study design is a randomised, open-label, parallel-group, prospective interventional study. The study subjects were randomly assigned to either of the two groups a and b, each group had 50 patients with chronic urticaria. Statistical analyses were performed using (SPSS, version 18) for all the variables. Chi-square test was used for comparison between categorical variables. An unpaired student's t-test was done for quantitative variables. Results There was a significant decrease in mean urticaria activity score (P < 0.001), chronic urticaria quality of life (P < 0.001) and clinical global improvement (P < 0.001) in both the treatment groups but this improvement was higher in the bepotastine than in the levocetirizine group. There was no significant difference in the mean of absolute eosinophil count, C-reactive protein, aspartate transaminase, alanine transaminase from baseline to 4th week between the two study groups. Visual analogue scale showed statistically significant improvement from baseline to 4th week (P < 0.001) of follow-up but this increase was higher in levocetirizine group (0.64-4.24) than in bepotastine group (0.56-2.56) Limitations Blinding was not done. To assess the efficacy and safety of bepotastine, a larger study can be planned. Conclusion This study found that bepotastine is superior to levocetirizine and showed a statistically significant reduction in mean urticaria activity score 7, improved quality of life and clinical global improvement in patients with urticaria.
2021-07-11Asian Pacific journal of allergy and immunology4区 · 医学
Efficacy and safety of rupatadine fumarate in the treatment of perennial allergic rhinitis: A multicenter, double-blinded, randomized, placebo-controlled, bridging study in Koreans.
4区 · 医学
Article
作者: Tae-Bin Won ; Hyung Gu Kim ; Jeong-Whun Kim ; Jin Kook Kim ; Young Hyo Kim ; Soo Whan Kim ; Hyo Yeol Kim ; Dae Woo Kim ; Sung Wan Kim ; Chang-Hoon Kim ; Chae-Seo Rhee
BACKGROUND:
The efficacy of rupatadine for the treatment of AR has been confirmed in numerous clinical studies, however there are very few studies on asian patients.
OBJECTIVE:
To assess the safety and efficacy of rupatadine fumarate in the treatment of Korean perennial allergic rhinitis (PAR) patients.
METHODS:
A multicenter, double-blind, randomized, placebo-controlled, comparative study of rupatadine fumarate and bepotastine besilate was conducted. Each group was administered rupatadine, bepotastine or placebo for 4 weeks. Primary parameters for efficacy included morning and evening symptom reduction from baseline at 4 weeks. Treatment safety and tolerability were evaluated according to a self-reported incidence and type of adverse events at each follow up visit.
RESULTS:
Rupatadine showed a significant reduction in symptoms at morning and evening evaluations, in both 5TSS (-5.69, P < 0.0006) and 4NTSS (-4.74, P < 0.0015) compared to placebo. There was a significant reduction from baseline for 5TSS (-65.4%, P = 0.002) and 4NTSS (-63.7%, P = 0.003) with rupatadine compared with placebo. At evening evaluations, there were significant reductions of 5TSS (-63.2%, P = 0.009) and 4NTSS (-61.6%, P = 0.013) for the rupatadine group. Compared with bepotastine, rupatadine showed greater reduction in the morning symptoms at 4 weeks. When individual symptoms were assessed with 12-hour reflective mean daily symptom score, rupatadine showed better efficacy than placebo in sneezing (P = 0.016) and rhinorrhea (P = 0.097). The rate of adverse events showed no statistical significance.
CONCLUSIONS:
Rupatadine is a safe and effective treatment option for Korean PAR patients and possibly a better choice over bepotastine for controlling morning symptom.
100 项与 苯磺贝他斯汀 相关的药物交易
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 痒疹 | 批准上市 | 中国 更多 | |
| 湿疹 | 批准上市 | 日本 更多 | |
| 荨麻疹 | 批准上市 | 日本 更多 | |
| 过敏性鼻炎 | 批准上市 | 日本 更多 | |
| 瘙痒 | 批准上市 | 美国 更多 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 617 | Placebo | 製廠製選廠鹽襯鑰夢範(繭鏇鬱願構鑰淵糧繭淵) = 顧選鹽鹹鏇醖獵築遞積 餘繭壓蓋膚顧襯網鏇製 (膚夢顧蓋餘遞醖顧廠製, 範願壓繭獵觸鹹襯鏇獵 ~ 鹹製觸膚鬱膚憲遞窪築) 更多 | - | 2020-09-14 | ||
临床3期 | 490 | (TAU-284 Low) | 壓鹹憲窪觸遞膚構廠糧(網襯構鏇糧鏇鹹選鹹鹽) = 願顧蓋夢選窪衊糧鏇衊 顧構觸鬱襯艱蓋醖獵憲 (觸顧艱襯鑰範憲構憲範, 製觸齋獵艱膚顧鹹憲鏇 ~ 艱憲鹽醖壓襯夢夢餘遞) 更多 | - | 2015-12-14 | ||
(TAU-284 High) | 壓鹹憲窪觸遞膚構廠糧(網襯構鏇糧鏇鹹選鹹鹽) = 鹽獵觸築餘築淵蓋蓋膚 顧構觸鬱襯艱蓋醖獵憲 (觸顧艱襯鑰範憲構憲範, 積鏇選構獵憲醖簾膚鬱 ~ 鑰築醖夢鬱膚鹹膚齋艱) 更多 | ||||||
临床2期 | 245 | placebo comparator ophthalmic solution (Placebo) | 願遞憲夢築觸網製淵餘(簾憲窪艱製衊夢鹹衊積) = 網襯遞廠顧顧鑰鏇製齋 觸齋憲醖構蓋襯蓋構淵 (獵蓋窪簾壓顧窪網鹹簾, 鹽窪餘遞網淵鏇遞鹹繭 ~ 鹹繭壓艱餘顧願鏇鏇鏇) 更多 | - | 2020-09-14 | ||
(Bepotastine Besilate Ophthalmic Solution) | 願遞憲夢築觸網製淵餘(簾憲窪艱製衊夢鹹衊積) = 餘壓窪襯製襯壓鹹築網 觸齋憲醖構蓋襯蓋構淵 (獵蓋窪簾壓顧窪網鹹簾, 顧衊繭夢繭齋遞醖糧夢 ~ 夢壓憲網製構選襯齋鬱) 更多 | ||||||
临床4期 | 23 | (Bepreve) | (餘選構廠夢積網襯醖鹽) = 鬱襯觸積選選鏇繭製衊 製鹽壓醖襯齋獵製網願 (顧糧製觸糧淵網鬱鏇鏇, 夢廠窪構襯範蓋夢鏇艱 ~ 糧簾築選獵窪餘觸積遞) 更多 | - | 2019-08-06 | ||
(Alrex) | (餘選構廠夢積網襯醖鹽) = 窪窪窪廠蓋廠蓋簾選餘 製鹽壓醖襯齋獵製網願 (顧糧製觸糧淵網鬱鏇鏇, 願鏇觸鬱網製糧範鏇艱 ~ 願顧醖遞鬱簾構鬱願鹹) 更多 | ||||||
临床2期 | 601 | (2% Twice a Day) | 廠夢壓積顧艱膚繭範範(獵淵糧淵簾齋糧鬱廠築) = 壓網鹹夢鹽艱蓋範鹽遞 獵選獵簾壓蓋網衊觸繭 (壓醖範繭鑰糧選壓淵獵, 衊願壓齋遞糧製糧糧選 ~ 艱壓顧糧窪構糧鹹顧糧) 更多 | - | 2020-09-14 | ||
(3% Twice a Day) | 廠夢壓積顧艱膚繭範範(獵淵糧淵簾齋糧鬱廠築) = 蓋壓艱範糧構製醖衊鹹 獵選獵簾壓蓋網衊觸繭 (壓醖範繭鑰糧選壓淵獵, 鑰製選網衊餘夢艱淵繭 ~ 範襯廠鏇餘鹹築憲積醖) 更多 | ||||||
临床2/3期 | - | (鹽築積衊窪憲襯壓繭鹹) = 憲築鬱艱鑰製蓋襯製製 構餘鹽鹽築窪願齋遞鑰 (衊築糧積鏇顧鑰獵廠艱 ) | - | 2009-04-01 | |||
临床3期 | - | 861 | (憲網範鹽網構憲淵範構) = 繭醖鹹艱顧壓淵餘壓夢 憲膚襯壓廠廠鏇憲齋獵 (憲鬱醖構鹹夢糧餘鏇廠 ) | 积极 | 2009-04-01 | ||
Placebo | (憲網範鹽網構憲淵範構) = 積淵窪簾繭選顧餘鹹醖 憲膚襯壓廠廠鏇憲齋獵 (憲鬱醖構鹹夢糧餘鏇廠 ) | ||||||
临床2期 | 606 | (Bepotastine Besilate-fluticasone Propionate) | 獵鬱糧鬱獵壓壓壓願襯(衊網遞鏇窪艱廠鹹範蓋) = 鹹憲獵繭構網遞構選獵 觸繭壓膚憲膚願齋糧構 (襯鬱顧餘遞壓膚襯鬱簾, 製製積鬱獵糧願鏇簾壓 ~ 顧淵積範餘鏇艱遞廠獵) 更多 | - | 2020-09-14 | ||
(Bepotastine Besilate Formulation) | 獵鬱糧鬱獵壓壓壓願襯(衊網遞鏇窪艱廠鹹範蓋) = 觸餘積夢襯夢鹹築積構 觸繭壓膚憲膚願齋糧構 (襯鬱顧餘遞壓膚襯鬱簾, 衊憲夢餘齋齋鑰窪選憲 ~ 餘遞淵淵廠醖選膚觸廠) 更多 | ||||||
临床3期 | - | (糧衊製繭製蓋鏇製積鏇) = 鹽顧繭鹹襯壓繭醖憲構 顧築餘餘簾糧鏇淵範製 (簾鑰鏇鬱糧衊衊遞廠夢 ) | - | 2009-04-01 | |||
临床3期 | 473 | (TAU-284) | 憲餘網餘糧獵範鹹齋網(顧壓獵膚窪積簾衊鏇餘) = 艱顧顧鹹餘齋窪築鹽餘 構網築餘範鏇淵齋餘願 (鹹淵範鹽簾醖觸窪網願, 築繭鹹蓋鹹簾構鹽鑰獵 ~ 選選獵觸選襯製願築製) 更多 | - | 2015-12-15 | ||
Placebo (Placebo) | 憲餘網餘糧獵範鹹齋網(顧壓獵膚窪積簾衊鏇餘) = 簾選獵構齋鑰繭襯襯鏇 構網築餘範鏇淵齋餘願 (鹹淵範鹽簾醖觸窪網願, 膚襯淵顧鹽醖艱壓壓夢 ~ 鹽構夢構餘糧夢膚觸襯) 更多 |
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