FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2413680969> ?p ?o ?g. }

• W2413680969 abstract "Introduction Data on mesalazine (5-aminosalicylic acid; 5-ASA) use in cases of paediatric ulcerative colitis (UC) are limited. In this phase 1, randomised, open-label, multicentre study ([NCT01130844][1]), pharmacokinetic (PK) and safety profiles of 5-ASA and metabolite acetyl-5-ASA (Ac-5-ASA) were examined in youth with UC diagnoses after once-daily (QD) multimatrix mesalazine administration.Method Upon enrolment, patients (pts; aged 5–17 y with diagnosis of UC ≥3 mo, stratified by body weight) were given 30, 60, or 100 mg/kg multimatrix mesalazine QD for 1 wk. The existing, approved, 1200 mg tablet was supplemented with newly developed, smaller-sized 300 and 600 mg multimatrix mesalazine tablets in order to achieve the appropriate study doses in children. Mesalazine was administered at home (Days 1–4) and at the clinic (Days 5–7); onsite, safety evaluations were performed, and blood and urine samples obtained for PK analyses. A validated LC/MS/MS assay was used to determine plasma and urine concentrations of 5-ASA and Ac-5-ASA. Key PK parameters assessed included maximum concentration (Cmax, ss), time of Cmax, ss (tmax), area under the curve for 1 dose interval (AUCss), renal clearance (CLR), and% dose absorbed.Results In total, 52 pts (21, 22, and 9 pts at 30, 60, and 100 mg/kg, respectively) were randomised and treated. Mean (standard deviation) age was 13.3 (3.1) y, and median (range) time since UC diagnosis was 1.8 (0.2–9.6) y. By Day 5, 5-ASA and Ac-5-ASA plasma concentrations reached steady state for all dose groups. On Day 7, for both 5-ASA and Ac-5-ASA, mean Cmax, ss and AUCssshowed dose proportional increases from 30 to 60 mg/kg cohorts. Mean% 5-ASA absorbed for 30, 60, and 100 mg/kg doses were 29.4%, 27.0%, and 22.1%, respectively. Mean CLR ranges were 5.0–6.5 L/h for 5-ASA and 10.0–16.2 L/h for Ac-5-ASA. Treatment-emergent adverse events (TEAEs) were reported by 19.2% of pts; no new safety signals were identified. Events were similar among age and dose groups, and no TEAEs led to premature discontinuation.Conclusion The PK profiles of 5-ASA and Ac-5-ASA in children and adolescents with UC receiving multimatrix mesalazine across all dose levels were similar to those from historical adult data with respect to absorption, clearance, and intersubject variability. Overall, multimatrix mesalazine was well tolerated with no new safety concerns identified.Disclosure of interest C. Cuffari Consultant for: Shire, Prometheus, Abbott Nutrition, D. Pierce Shareholder of: Shire, GlaxoSmithKline, Employee of: Former employee of Shire, B. Korczowski Grant/Research Support from: Shire, K. Fyderek Grant/ Research Support from: Shire, H. Van Heusen Shareholder of: Shire, Employee of: Shire, S. Hossack Employee of: Covance, which received funding from Shire, P. Martin Shareholder of: Shire, Employee of: Shire. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01130844&atom=%2Fgutjnl%2F64%2FSuppl_1%2FA101.1.atom" @default.
• W2413680969 created "2016-06-24" @default.
• W2413680969 creator A5016046647 @default.
• W2413680969 creator A5034348074 @default.
• W2413680969 creator A5039416314 @default.
• W2413680969 creator A5044068509 @default.
• W2413680969 creator A5044937555 @default.
• W2413680969 creator A5052909880 @default.
• W2413680969 creator A5071484436 @default.
• W2413680969 date "2015-06-01" @default.
• W2413680969 modified "2023-09-27" @default.
• W2413680969 title "PTU-091 Multimatrix mesalazine in paediatric ulcerative colitis: a pharmacokinetic and safety study" @default.
• W2413680969 doi "https://doi.org/10.1136/gutjnl-2015-309861.206" @default.
• W2413680969 hasPublicationYear "2015" @default.
• W2413680969 type Work @default.
• W2413680969 sameAs 2413680969 @default.
• W2413680969 citedByCount "0" @default.
• W2413680969 crossrefType "journal-article" @default.
• W2413680969 hasAuthorship W2413680969A5016046647 @default.
• W2413680969 hasAuthorship W2413680969A5034348074 @default.
• W2413680969 hasAuthorship W2413680969A5039416314 @default.
• W2413680969 hasAuthorship W2413680969A5044068509 @default.
• W2413680969 hasAuthorship W2413680969A5044937555 @default.
• W2413680969 hasAuthorship W2413680969A5052909880 @default.
• W2413680969 hasAuthorship W2413680969A5071484436 @default.
• W2413680969 hasConcept C112705442 @default.
• W2413680969 hasConcept C126322002 @default.
• W2413680969 hasConcept C22979827 @default.
• W2413680969 hasConcept C2779134260 @default.
• W2413680969 hasConcept C2779174533 @default.
• W2413680969 hasConcept C2780026642 @default.
• W2413680969 hasConcept C2780479503 @default.
• W2413680969 hasConcept C71924100 @default.
• W2413680969 hasConcept C76318530 @default.
• W2413680969 hasConcept C90924648 @default.
• W2413680969 hasConcept C98274493 @default.
• W2413680969 hasConceptScore W2413680969C112705442 @default.
• W2413680969 hasConceptScore W2413680969C126322002 @default.
• W2413680969 hasConceptScore W2413680969C22979827 @default.
• W2413680969 hasConceptScore W2413680969C2779134260 @default.
• W2413680969 hasConceptScore W2413680969C2779174533 @default.
• W2413680969 hasConceptScore W2413680969C2780026642 @default.
• W2413680969 hasConceptScore W2413680969C2780479503 @default.
• W2413680969 hasConceptScore W2413680969C71924100 @default.
• W2413680969 hasConceptScore W2413680969C76318530 @default.
• W2413680969 hasConceptScore W2413680969C90924648 @default.
• W2413680969 hasConceptScore W2413680969C98274493 @default.
• W2413680969 hasLocation W24136809691 @default.
• W2413680969 hasOpenAccess W2413680969 @default.
• W2413680969 hasPrimaryLocation W24136809691 @default.
• W2413680969 hasRelatedWork W1489745947 @default.
• W2413680969 hasRelatedWork W1969026706 @default.
• W2413680969 hasRelatedWork W1978813423 @default.
• W2413680969 hasRelatedWork W1981383291 @default.
• W2413680969 hasRelatedWork W1991379864 @default.
• W2413680969 hasRelatedWork W2091211837 @default.
• W2413680969 hasRelatedWork W2097014393 @default.
• W2413680969 hasRelatedWork W2141787758 @default.
• W2413680969 hasRelatedWork W2147825834 @default.
• W2413680969 hasRelatedWork W2181958891 @default.
• W2413680969 hasRelatedWork W2326375399 @default.
• W2413680969 hasRelatedWork W2546852319 @default.
• W2413680969 hasRelatedWork W2596295815 @default.
• W2413680969 hasRelatedWork W2756472171 @default.
• W2413680969 hasRelatedWork W2807925291 @default.
• W2413680969 hasRelatedWork W2947762727 @default.
• W2413680969 hasRelatedWork W3042563287 @default.
• W2413680969 hasRelatedWork W3045697709 @default.
• W2413680969 hasRelatedWork W3177137789 @default.
• W2413680969 hasRelatedWork W1978225850 @default.
• W2413680969 isParatext "false" @default.
• W2413680969 isRetracted "false" @default.
• W2413680969 magId "2413680969" @default.
• W2413680969 workType "article" @default.