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Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: a randomized, multi‐center, placebo‐controlled trial
Summary Background Mitemcinal, an oral motilin agonist, accelerates gastric emptying. Aim To investigate if mitemcinal was superior to placebo in relief of symptoms attributed to gastroparesis. Methods In a randomized, double‐blind design, 392 insulin‐requiring diabetics with symptoms attributable t...
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| Published in: | Alimentary pharmacology & therapeutics 2007-07, Vol.26 (1), p.107-116 |
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| container_title | Alimentary pharmacology & therapeutics |
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| creator | MCCALLUM, R. W. CYNSHI, O. |
| description | Summary
Background Mitemcinal, an oral motilin agonist, accelerates gastric emptying.
Aim To investigate if mitemcinal was superior to placebo in relief of symptoms attributed to gastroparesis.
Methods In a randomized, double‐blind design, 392 insulin‐requiring diabetics with symptoms attributable to gastroparesis were treated for 3 months with placebo, mitemcinal 5 or 10 mg bid. On a weekly basis, patients assessed whether there was adequate relief of their gastroparesis symptoms. Patients were classified as Complete Responders (CR) if there were three consecutive positive monthly responses, which required at least 50% of their weekly responses in a month being positive. An Overall Responder (OR) had at least 75% positive weekly responses for the whole treatment period.
Results Mitemcinal 10 mg produced a significantly better response rate than placebo with a 10.6% increase in the OR (P |
| doi_str_mv | 10.1111/j.1365-2036.2007.03346.x |
| format | article |
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Background Mitemcinal, an oral motilin agonist, accelerates gastric emptying.
Aim To investigate if mitemcinal was superior to placebo in relief of symptoms attributed to gastroparesis.
Methods In a randomized, double‐blind design, 392 insulin‐requiring diabetics with symptoms attributable to gastroparesis were treated for 3 months with placebo, mitemcinal 5 or 10 mg bid. On a weekly basis, patients assessed whether there was adequate relief of their gastroparesis symptoms. Patients were classified as Complete Responders (CR) if there were three consecutive positive monthly responses, which required at least 50% of their weekly responses in a month being positive. An Overall Responder (OR) had at least 75% positive weekly responses for the whole treatment period.
Results Mitemcinal 10 mg produced a significantly better response rate than placebo with a 10.6% increase in the OR (P < 0.05 vs. placebo). Mitemcinal 10 mg also produced statistically significant increases in the CR and OR in the subgroup identified by baseline body mass index (<35 kg/m2) and haemoglobin A1c (<10%) (P < 0.01 vs. placebo). Adverse events did not differ from placebo frequency levels.
Conclusions Mitemcinal can induce a statistically significant response to treatment in a subset of diabetic gastroparesis where future prokinetic clinical trials should be focused.</description><identifier>ISSN: 0269-2813</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1111/j.1365-2036.2007.03346.x</identifier><identifier>PMID: 17555427</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adolescent ; Biological and medical sciences ; Child ; Child, Preschool ; Diabetes. Impaired glucose tolerance ; Digestive system ; Dose-Response Relationship, Drug ; Double-Blind Method ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Etiopathogenesis. Screening. Investigations. Target tissue resistance ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Gastrointestinal Agents - therapeutic use ; Gastroparesis - drug therapy ; Humans ; Male ; Medical sciences ; Motilin - pharmacokinetics ; Motilin - therapeutic use ; Pharmacology. Drug treatments ; Safety ; Treatment Outcome</subject><ispartof>Alimentary pharmacology & therapeutics, 2007-07, Vol.26 (1), p.107-116</ispartof><rights>2007 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4476-f9746283838823e4ebe8d05b94cbc45eb3a1b09c68aca33b089e45bd8c0e287c3</citedby><cites>FETCH-LOGICAL-c4476-f9746283838823e4ebe8d05b94cbc45eb3a1b09c68aca33b089e45bd8c0e287c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18833502$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17555427$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>MCCALLUM, R. W.</creatorcontrib><creatorcontrib>CYNSHI, O.</creatorcontrib><creatorcontrib>US INVESTIGATIVE TEAM</creatorcontrib><creatorcontrib>US INVESTIGATIVE TEAM</creatorcontrib><title>Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: a randomized, multi‐center, placebo‐controlled trial</title><title>Alimentary pharmacology & therapeutics</title><addtitle>Aliment Pharmacol Ther</addtitle><description>Summary
Background Mitemcinal, an oral motilin agonist, accelerates gastric emptying.
Aim To investigate if mitemcinal was superior to placebo in relief of symptoms attributed to gastroparesis.
Methods In a randomized, double‐blind design, 392 insulin‐requiring diabetics with symptoms attributable to gastroparesis were treated for 3 months with placebo, mitemcinal 5 or 10 mg bid. On a weekly basis, patients assessed whether there was adequate relief of their gastroparesis symptoms. Patients were classified as Complete Responders (CR) if there were three consecutive positive monthly responses, which required at least 50% of their weekly responses in a month being positive. An Overall Responder (OR) had at least 75% positive weekly responses for the whole treatment period.
Results Mitemcinal 10 mg produced a significantly better response rate than placebo with a 10.6% increase in the OR (P < 0.05 vs. placebo). Mitemcinal 10 mg also produced statistically significant increases in the CR and OR in the subgroup identified by baseline body mass index (<35 kg/m2) and haemoglobin A1c (<10%) (P < 0.01 vs. placebo). Adverse events did not differ from placebo frequency levels.
Conclusions Mitemcinal can induce a statistically significant response to treatment in a subset of diabetic gastroparesis where future prokinetic clinical trials should be focused.</description><subject>Adolescent</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Digestive system</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Endocrine pancreas. Apud cells (diseases)</subject><subject>Endocrinopathies</subject><subject>Etiopathogenesis. Screening. Investigations. Target tissue resistance</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Gastrointestinal Agents - therapeutic use</subject><subject>Gastroparesis - drug therapy</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Motilin - pharmacokinetics</subject><subject>Motilin - therapeutic use</subject><subject>Pharmacology. Drug treatments</subject><subject>Safety</subject><subject>Treatment Outcome</subject><issn>0269-2813</issn><issn>1365-2036</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><recordid>eNqNkc2O1SAYhonROMfRWzBsdHVaKfSHmriYTMafZBJdjGtC6dcOJ1BqoZnprLwE78e78UqkcxrPVlhA-J73_YAXIZyRNIvj3SHNWFkklLAypYRUKWEsL9P7J2j3r_AU7Qgt64TyjJ2hF94fCCFlRehzdJZVRVHktNqh31ddp5VUC3YdtjqAVXqQZo8lti5oowcsezdoH_bYDbiXPkxODwF8WDnsFzsGZz2O4CiDhiF4fKfD7ani575_xHvcatlA0GrziYLb5X1sNcmhdVY_QLvHdjZB__n5S0UrmPZ4NFJB49YTN0SRMdDiMGlpXqJnnTQeXm3rOfr-8erm8nNy_fXTl8uL60TleVUmXV3lJeUsTk4Z5NAAb0nR1LlqVF5Aw2TWkFqVXCrJWEN4DXnRtFwRoLxS7By9PfqOk_sxx6cIq70CY-QAbvaiIkVNa1ZHkB9BNTnvJ-jEOGkrp0VkRKzBiYNY8xFrPmINTjwGJ-6j9PXWY24stCfhllQE3myA9EqaLn6Z0v7Ecc5YQWjkPhy5O21g-e8LiItvN-uO_QVZ3ruP</recordid><startdate>200707</startdate><enddate>200707</enddate><creator>MCCALLUM, R. W.</creator><creator>CYNSHI, O.</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>200707</creationdate><title>Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: a randomized, multi‐center, placebo‐controlled trial</title><author>MCCALLUM, R. W. ; CYNSHI, O.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4476-f9746283838823e4ebe8d05b94cbc45eb3a1b09c68aca33b089e45bd8c0e287c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Adolescent</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Diabetes. Impaired glucose tolerance</topic><topic>Digestive system</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Endocrine pancreas. Apud cells (diseases)</topic><topic>Endocrinopathies</topic><topic>Etiopathogenesis. Screening. Investigations. Target tissue resistance</topic><topic>Female</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Gastrointestinal Agents - therapeutic use</topic><topic>Gastroparesis - drug therapy</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Motilin - pharmacokinetics</topic><topic>Motilin - therapeutic use</topic><topic>Pharmacology. Drug treatments</topic><topic>Safety</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>MCCALLUM, R. W.</creatorcontrib><creatorcontrib>CYNSHI, O.</creatorcontrib><creatorcontrib>US INVESTIGATIVE TEAM</creatorcontrib><creatorcontrib>US INVESTIGATIVE TEAM</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>MCCALLUM, R. W.</au><au>CYNSHI, O.</au><aucorp>US INVESTIGATIVE TEAM</aucorp><aucorp>US INVESTIGATIVE TEAM</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: a randomized, multi‐center, placebo‐controlled trial</atitle><jtitle>Alimentary pharmacology & therapeutics</jtitle><addtitle>Aliment Pharmacol Ther</addtitle><date>2007-07</date><risdate>2007</risdate><volume>26</volume><issue>1</issue><spage>107</spage><epage>116</epage><pages>107-116</pages><issn>0269-2813</issn><eissn>1365-2036</eissn><abstract>Summary
Background Mitemcinal, an oral motilin agonist, accelerates gastric emptying.
Aim To investigate if mitemcinal was superior to placebo in relief of symptoms attributed to gastroparesis.
Methods In a randomized, double‐blind design, 392 insulin‐requiring diabetics with symptoms attributable to gastroparesis were treated for 3 months with placebo, mitemcinal 5 or 10 mg bid. On a weekly basis, patients assessed whether there was adequate relief of their gastroparesis symptoms. Patients were classified as Complete Responders (CR) if there were three consecutive positive monthly responses, which required at least 50% of their weekly responses in a month being positive. An Overall Responder (OR) had at least 75% positive weekly responses for the whole treatment period.
Results Mitemcinal 10 mg produced a significantly better response rate than placebo with a 10.6% increase in the OR (P < 0.05 vs. placebo). Mitemcinal 10 mg also produced statistically significant increases in the CR and OR in the subgroup identified by baseline body mass index (<35 kg/m2) and haemoglobin A1c (<10%) (P < 0.01 vs. placebo). Adverse events did not differ from placebo frequency levels.
Conclusions Mitemcinal can induce a statistically significant response to treatment in a subset of diabetic gastroparesis where future prokinetic clinical trials should be focused.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>17555427</pmid><doi>10.1111/j.1365-2036.2007.03346.x</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Biological and medical sciences Child Child, Preschool Diabetes. Impaired glucose tolerance Digestive system Dose-Response Relationship, Drug Double-Blind Method Endocrine pancreas. Apud cells (diseases) Endocrinopathies Etiopathogenesis. Screening. Investigations. Target tissue resistance Female Gastroenterology. Liver. Pancreas. Abdomen Gastrointestinal Agents - therapeutic use Gastroparesis - drug therapy Humans Male Medical sciences Motilin - pharmacokinetics Motilin - therapeutic use Pharmacology. Drug treatments Safety Treatment Outcome |
| title | Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: a randomized, multi‐center, placebo‐controlled trial |
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