Once daily MMX mesalazine for the treatment of mild‐to‐moderate ulcerative colitis: a phase II, dose‐ranging study

Summary Background  SPD476 (MMX™ mesalazine), is a novel, once daily, high‐strength mesalazine formulation (1.2 g/tablet) that utilizes Multi Matrix System™ (MMX) technology to delay and extend delivery of the active drug throughout the colon. Aim  To assess the safety and efficacy of MMX mesalazine...

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Published in:Alimentary pharmacology & therapeutics 2006-10, Vol.24 (7), p.1087-1097
Main Authors: D'HAENS, G., HOMMES, D., ENGELS, L., BAERT, F., VAN DER WAAIJ, L., CONNOR, P., RAMAGE, J., DEWIT, O., PALMEN, M., STEPHENSON, D., JOSEPH, R.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Anti-Inflammatory Agents, Non-Steroidal - administration & dosage
Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics
Biological and medical sciences
Colitis, Ulcerative - drug therapy
Digestive system
Double-Blind Method
Drug Administration Schedule
Female
Gastroenterology. Liver. Pancreas. Abdomen
Humans
Male
Medical sciences
Mesalamine - administration & dosage
Mesalamine - pharmacokinetics
Middle Aged
Other diseases. Semiology
Pharmacology. Drug treatments
Stomach. Duodenum. Small intestine. Colon. Rectum. Anus
Treatment Outcome
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Summary:Summary Background  SPD476 (MMX™ mesalazine), is a novel, once daily, high‐strength mesalazine formulation (1.2 g/tablet) that utilizes Multi Matrix System™ (MMX) technology to delay and extend delivery of the active drug throughout the colon. Aim  To assess the safety and efficacy of MMX mesalazine in patients with mild‐to‐moderately active ulcerative colitis, in a pilot, phase II, randomized, multicentre, double‐blind, parallel‐group, dose‐ranging study (SPD476‐202). Methods  Thirty‐eight patients with mild‐to‐moderately active ulcerative colitis were randomized to MMX mesalazine 1.2, 2.4 or 4.8 g/day given once daily for 8 weeks. Remission ulcerative colitis‐disease activity index (UC‐DAI) ≤1, a score of 0 for rectal bleeding and stool frequency, and ≥1‐point reduction in sigmoidoscopy score from baseline was the primary end point. Results  Week 8 remission rates were 0%, 31% and 18% of patients receiving MMX mesalazine 1.2, 2.4 and 4.8 g/day respectively. No statistically significant difference in remission was observed between treatment groups. MMX mesalazine 2.4 and 4.8 g/day groups demonstrated greater improvement in overall UC‐DAI and component scores from baseline, compared with the 1.2 g/day group. Conclusion  MMX mesalazine given as 2.4 or 4.8 g/day once daily is well tolerated and effective for the treatment of mild‐to‐moderately active ulcerative colitis.
ISSN:0269-2813
1365-2036
DOI:10.1111/j.1365-2036.2006.03082.x