| Clinical trial: randomized-controlled clinical study comparing the efficacy and safety of a low-volume vs. a high-volume mesalazine foam in active distal ulcerative colitis. | |
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MedLine Citation:
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PMID: 17944738 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Rectally administered mesalazine (mesalamine; 5-aminosalicylic acid) is the first-line therapy for treatment of distal ulcerative colitis. Recently, a high-volume 5-aminosalicylic acid foam has been shown to be as effective and safe as standard 5-aminosalicylic acid enema. AIM: To study the efficacy and safety of a low-volume vs. a high-volume 5-aminosalicylic acid foam. METHODS: In this investigator-blinded study, patients with active distal ulcerative colitis [Clinical Activity Index (CAI) > 4, Endoscopic Index > or = 4] were randomized to receive 2 x 1 g/30 mL low-volume (n = 163) or 2 x 1 g/60 mL high-volume 5-aminosalicylic acid foam (n = 167) for 42 days. Primary end point was clinical remission (CAI < or = 4) at the final/withdrawal visit (per-protocol). RESULTS: 330 patients were evaluable for efficacy and safety by intention-to-treat, 290 for per-protocol analysis. Clinical remission rates at week 6 (per-protocol) were 77% on low-volume foam vs. 77% on high-volume foam (P = 0.00002 for non-inferiority). The low-volume foam was associated with a lower frequency of severe discomfort, pain and retention problems. CONCLUSIONS: Low-volume 5-aminosalicylic acid foam is as effective and safe as a high-volume 5-aminosalicylic acid foam in the treatment of active distal ulcerative colitis, but offers compliance advantages compared to the high-volume preparation. |
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Authors:
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R Eliakim; Z Tulassay; L Kupcinskas; K Adamonis; J Pokrotnieks; S Bar-Meir; A Lavy; R Mueller; R Greinwald; I Chermesh; V Gross; |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Alimentary pharmacology & therapeutics Volume: 26 ISSN: 0269-2813 ISO Abbreviation: Aliment. Pharmacol. Ther. Publication Date: 2007 Nov |
Date Detail:
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Created Date: 2007-10-19 Completed Date: 2008-03-14 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8707234 Medline TA: Aliment Pharmacol Ther Country: England |
Other Details:
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Languages: eng Pagination: 1237-49 Citation Subset: IM |
Affiliation:
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Gastroenterology Department, Rambam Medical Center, Haifa, Israel. r_eliakim@rambam.health.gov.il |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Rectal Adolescent Adult Aged Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*, adverse effects, therapeutic use Colitis, Ulcerative / drug therapy* Female Humans Male Mesalamine / administration & dosage*, adverse effects, therapeutic use Middle Aged Single-Blind Method Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents, Non-Steroidal; 89-57-6/Mesalamine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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