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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| Veröffentlicht in: | Alimentary pharmacology & therapeutics 2006-10, Vol.24 (7), p.1087-1097 |
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| container_title | Alimentary pharmacology & therapeutics |
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| creator | 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. |
| description | 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. |
| doi_str_mv | 10.1111/j.1365-2036.2006.03082.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_68870873</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>68870873</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5132-af7a79a7c7984efdb276fb2bb1b5a5da0c11fa270beb7f7042cf430baa1f940f3</originalsourceid><addsrcrecordid>eNqNkMtu1DAUhi0EokPhFZA3sCLBlyROkFhUFYWRWpVFkdhZJ85x65GTDHYCM13xCDwjT4LDjOgWL-xf8ncu-gihnOU8nbebnMuqzASTVS4Yq3ImWS3y3SOy-vfxmKyYqJpM1FyekGcxblgiFRNPyQmvmroomVyR3fVgkHbg_J5eXX2lPUbwcO8GpHYMdLpDOgWEqcdhoqOlvfPd75-_pjFd_dhhgAnp7M0S3HekZvRucvEdBbq9g4h0vX5DuzFi4gMMt264pXGau_1z8sSCj_ji-J6SLxcfbs4_ZZfXH9fnZ5eZKbkUGVgFqgFlVNoYbdcKVdlWtC1vSyg7YIZzC0KxFltlFSuEsYVkLQC3TcGsPCWvD323Yfw2Y5x076JB72HAcY66qmvFaiUTWB9AE8YYA1q9Da6HsNec6cW63uhFrl7k6sW6_mtd71Lpy-OMue2xeyg8ak7AqyMA0YC3yYRx8YGrORNFwxP3_sD9cB73_72APvt8syT5B7Xzogc</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>68870873</pqid></control><display><type>article</type><title>Once daily MMX mesalazine for the treatment of mild‐to‐moderate ulcerative colitis: a phase II, dose‐ranging study</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Wiley Free Content</source><source>IngentaConnect Free/Open Access Journals</source><source>Wiley Online Library All Journals</source><creator>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.</creator><creatorcontrib>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.</creatorcontrib><description>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.</description><identifier>ISSN: 0269-2813</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1111/j.1365-2036.2006.03082.x</identifier><identifier>PMID: 16984503</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>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</subject><ispartof>Alimentary pharmacology & therapeutics, 2006-10, Vol.24 (7), p.1087-1097</ispartof><rights>2006 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5132-af7a79a7c7984efdb276fb2bb1b5a5da0c11fa270beb7f7042cf430baa1f940f3</citedby><cites>FETCH-LOGICAL-c5132-af7a79a7c7984efdb276fb2bb1b5a5da0c11fa270beb7f7042cf430baa1f940f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1365-2036.2006.03082.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1365-2036.2006.03082.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1416,1432,27923,27924,45573,45574,46408,46832</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18102491$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16984503$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>D'HAENS, G.</creatorcontrib><creatorcontrib>HOMMES, D.</creatorcontrib><creatorcontrib>ENGELS, L.</creatorcontrib><creatorcontrib>BAERT, F.</creatorcontrib><creatorcontrib>VAN DER WAAIJ, L.</creatorcontrib><creatorcontrib>CONNOR, P.</creatorcontrib><creatorcontrib>RAMAGE, J.</creatorcontrib><creatorcontrib>DEWIT, O.</creatorcontrib><creatorcontrib>PALMEN, M.</creatorcontrib><creatorcontrib>STEPHENSON, D.</creatorcontrib><creatorcontrib>JOSEPH, R.</creatorcontrib><title>Once daily MMX mesalazine for the treatment of mild‐to‐moderate ulcerative colitis: a phase II, dose‐ranging study</title><title>Alimentary pharmacology & therapeutics</title><addtitle>Aliment Pharmacol Ther</addtitle><description>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.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - administration & dosage</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics</subject><subject>Biological and medical sciences</subject><subject>Colitis, Ulcerative - drug therapy</subject><subject>Digestive system</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Mesalamine - administration & dosage</subject><subject>Mesalamine - pharmacokinetics</subject><subject>Middle Aged</subject><subject>Other diseases. Semiology</subject><subject>Pharmacology. Drug treatments</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</subject><subject>Treatment Outcome</subject><issn>0269-2813</issn><issn>1365-2036</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkMtu1DAUhi0EokPhFZA3sCLBlyROkFhUFYWRWpVFkdhZJ85x65GTDHYCM13xCDwjT4LDjOgWL-xf8ncu-gihnOU8nbebnMuqzASTVS4Yq3ImWS3y3SOy-vfxmKyYqJpM1FyekGcxblgiFRNPyQmvmroomVyR3fVgkHbg_J5eXX2lPUbwcO8GpHYMdLpDOgWEqcdhoqOlvfPd75-_pjFd_dhhgAnp7M0S3HekZvRucvEdBbq9g4h0vX5DuzFi4gMMt264pXGau_1z8sSCj_ji-J6SLxcfbs4_ZZfXH9fnZ5eZKbkUGVgFqgFlVNoYbdcKVdlWtC1vSyg7YIZzC0KxFltlFSuEsYVkLQC3TcGsPCWvD323Yfw2Y5x076JB72HAcY66qmvFaiUTWB9AE8YYA1q9Da6HsNec6cW63uhFrl7k6sW6_mtd71Lpy-OMue2xeyg8ak7AqyMA0YC3yYRx8YGrORNFwxP3_sD9cB73_72APvt8syT5B7Xzogc</recordid><startdate>200610</startdate><enddate>200610</enddate><creator>D'HAENS, G.</creator><creator>HOMMES, D.</creator><creator>ENGELS, L.</creator><creator>BAERT, F.</creator><creator>VAN DER WAAIJ, L.</creator><creator>CONNOR, P.</creator><creator>RAMAGE, J.</creator><creator>DEWIT, O.</creator><creator>PALMEN, M.</creator><creator>STEPHENSON, D.</creator><creator>JOSEPH, R.</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>200610</creationdate><title>Once daily MMX mesalazine for the treatment of mild‐to‐moderate ulcerative colitis: a phase II, dose‐ranging study</title><author>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.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5132-af7a79a7c7984efdb276fb2bb1b5a5da0c11fa270beb7f7042cf430baa1f940f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - administration & dosage</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics</topic><topic>Biological and medical sciences</topic><topic>Colitis, Ulcerative - drug therapy</topic><topic>Digestive system</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Mesalamine - administration & dosage</topic><topic>Mesalamine - pharmacokinetics</topic><topic>Middle Aged</topic><topic>Other diseases. Semiology</topic><topic>Pharmacology. Drug treatments</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>D'HAENS, G.</creatorcontrib><creatorcontrib>HOMMES, D.</creatorcontrib><creatorcontrib>ENGELS, L.</creatorcontrib><creatorcontrib>BAERT, F.</creatorcontrib><creatorcontrib>VAN DER WAAIJ, L.</creatorcontrib><creatorcontrib>CONNOR, P.</creatorcontrib><creatorcontrib>RAMAGE, J.</creatorcontrib><creatorcontrib>DEWIT, O.</creatorcontrib><creatorcontrib>PALMEN, M.</creatorcontrib><creatorcontrib>STEPHENSON, D.</creatorcontrib><creatorcontrib>JOSEPH, R.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Alimentary pharmacology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>D'HAENS, G.</au><au>HOMMES, D.</au><au>ENGELS, L.</au><au>BAERT, F.</au><au>VAN DER WAAIJ, L.</au><au>CONNOR, P.</au><au>RAMAGE, J.</au><au>DEWIT, O.</au><au>PALMEN, M.</au><au>STEPHENSON, D.</au><au>JOSEPH, R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Once daily MMX mesalazine for the treatment of mild‐to‐moderate ulcerative colitis: a phase II, dose‐ranging study</atitle><jtitle>Alimentary pharmacology & therapeutics</jtitle><addtitle>Aliment Pharmacol Ther</addtitle><date>2006-10</date><risdate>2006</risdate><volume>24</volume><issue>7</issue><spage>1087</spage><epage>1097</epage><pages>1087-1097</pages><issn>0269-2813</issn><eissn>1365-2036</eissn><abstract>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.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>16984503</pmid><doi>10.1111/j.1365-2036.2006.03082.x</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Wiley Free Content; IngentaConnect Free/Open Access Journals; Wiley Online Library All Journals |
| 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 |
| title | Once daily MMX mesalazine for the treatment of mild‐to‐moderate ulcerative colitis: a phase II, dose‐ranging study |
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