A Phase II dose ranging, double‐blind, placebo‐controlled study of alicaforsen enema in subjects with acute exacerbation of mild to moderate left‐sided ulcerative colitis

• Published in: Alimentary pharmacology & therapeutics Vol. 23; no. 10; pp. 1415 - 1425
• Main Authors: VAN DEVENTER, S. J. H., WEDEL, M. K., BAKER, B. F., XIA, S., CHUANG, E., MINER, P. B.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 15.05.2006; Blackwell
• Subjects: Adult; Aged; Biological and medical sciences; Colitis, Ulcerative - drug therapy; Digestive system; Double-Blind Method; Drug Administration Schedule; Enema; Female; Gastroenterology. Liver. Pancreas. Abdomen; Gastrointestinal Agents - administration & dosage; Gastrointestinal Agents - adverse effects; Gastrointestinal Hemorrhage - etiology; Humans; Male; Medical sciences; Middle Aged; Oligodeoxyribonucleotides, Antisense - administration & dosage; Oligodeoxyribonucleotides, Antisense - adverse effects; Other diseases. Semiology; Pharmacology. Drug treatments; Phosphorothioate Oligonucleotides; Rectum; Recurrence; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Thionucleotides - administration & dosage; Thionucleotides - adverse effects; Treatment Outcome; Alicaforsen; Human; Left; Acute; Antisense oligonucleotide; Inflammatory disease; Enema; Exacerbation; Placebo; Dosage form; Double blind study; Sudden infant death syndrome; Digestive diseases; Intestinal disease; Dose; Ulcerative colitis

Summary Background Alicaforsen is an antisense oligonucleotide designed to inhibit expression of human intercellular adhesion molecule 1. Previous clinical studies have demonstrated activity of alicaforsen enema in ulcerative colitis and pouchitis. Aim To determine the minimally effective dosing reg...