The effects of camicinal, a novel motilin agonist, on gastro‐esophageal function in healthy humans—a randomized placebo controlled trial
Background A proportion of patients with foregut dysmotility fail to respond to standard interventions. Motilin agonists may be beneficial in this group. We aimed to determine the effect of camicinal, a novel motilin agonist, on gastrointestinal physiology in healthy volunteers. Methods Healthy male...
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| Veröffentlicht in: | Neurogastroenterology and motility 2015-11, Vol.27 (11), p.1629-1637 |
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| container_title | Neurogastroenterology and motility |
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| creator | Hobson, R. Farmer, A. D. Dewit, O. E. O'Donnell, M. Hacquoil, K. Robertson, D. Barton, M. E. Dukes, G. E. |
| description | Background
A proportion of patients with foregut dysmotility fail to respond to standard interventions. Motilin agonists may be beneficial in this group. We aimed to determine the effect of camicinal, a novel motilin agonist, on gastrointestinal physiology in healthy volunteers.
Methods
Healthy male subjects were randomly assigned to receive a single dose of 125 mg camicinal or placebo in a double‐blind cross‐over design. Esophageal function and reflux indices were assessed using high‐resolution manometry (pre and 1.5‐h post dose) and 24‐h ambulatory multichannel intraluminal impedance/pH. After a standardized meal, subjects ingested a wireless motility capsule from which compartmental transit times and motility indices were derived. Subjects were restudied with the alternate intervention after 7 days.
Key Results
The study subjects (12 male, mean age 47.4 years, range 22–55) tolerated the drug well, except one who exhibited mild abdominal pain on both placebo and camicinal. In comparison to placebo, gastric emptying time (GET) was accelerated following camicinal (−115.4 min, 95% confidence interval −194.4, −36.4, p = 0.009). No effect was demonstrable on esophageal function, small bowel, colonic, or whole bowel transit times and motility indices. With camicinal, as part of a post hoc analysis, there was a trend association between the percentage reduction in GET and total number of acidic reflux events (r = 0.56, p = 0.09).
Conclusions & Inferences
Camicinal decreases GET and was generally well‐tolerated. In health, the direct effects of camicinal are on accelerating GET with a potential secondary benefit of reducing reflux events, which warrant further exploration in patient cohorts.
Camicinal, a novel motilin agonist, accelerates gastric emptying but has no discernable effect on esophageal function, small bowel, colonic, or whole gut transit times/motility indices in healthy humans.
View the podcast on this paper at the following sites:iTunes: https://itunes.apple.com/dk/podcast/neurogastroenterology-motility/id1045893519Youtube: https://youtu.be/DcjApg3j8yU |
| doi_str_mv | 10.1111/nmo.12663 |
| format | Article |
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A proportion of patients with foregut dysmotility fail to respond to standard interventions. Motilin agonists may be beneficial in this group. We aimed to determine the effect of camicinal, a novel motilin agonist, on gastrointestinal physiology in healthy volunteers.
Methods
Healthy male subjects were randomly assigned to receive a single dose of 125 mg camicinal or placebo in a double‐blind cross‐over design. Esophageal function and reflux indices were assessed using high‐resolution manometry (pre and 1.5‐h post dose) and 24‐h ambulatory multichannel intraluminal impedance/pH. After a standardized meal, subjects ingested a wireless motility capsule from which compartmental transit times and motility indices were derived. Subjects were restudied with the alternate intervention after 7 days.
Key Results
The study subjects (12 male, mean age 47.4 years, range 22–55) tolerated the drug well, except one who exhibited mild abdominal pain on both placebo and camicinal. In comparison to placebo, gastric emptying time (GET) was accelerated following camicinal (−115.4 min, 95% confidence interval −194.4, −36.4, p = 0.009). No effect was demonstrable on esophageal function, small bowel, colonic, or whole bowel transit times and motility indices. With camicinal, as part of a post hoc analysis, there was a trend association between the percentage reduction in GET and total number of acidic reflux events (r = 0.56, p = 0.09).
Conclusions & Inferences
Camicinal decreases GET and was generally well‐tolerated. In health, the direct effects of camicinal are on accelerating GET with a potential secondary benefit of reducing reflux events, which warrant further exploration in patient cohorts.
Camicinal, a novel motilin agonist, accelerates gastric emptying but has no discernable effect on esophageal function, small bowel, colonic, or whole gut transit times/motility indices in healthy humans.
View the podcast on this paper at the following sites:iTunes: https://itunes.apple.com/dk/podcast/neurogastroenterology-motility/id1045893519Youtube: https://youtu.be/DcjApg3j8yU</description><identifier>ISSN: 1350-1925</identifier><identifier>EISSN: 1365-2982</identifier><identifier>DOI: 10.1111/nmo.12663</identifier><identifier>PMID: 26348542</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Adult ; Capsule Endoscopy ; Cross-Over Studies ; Double-Blind Method ; Esophagogastric Junction - drug effects ; Gastric Emptying - drug effects ; Gastrointestinal Agents - pharmacology ; gastro‐esophageal reflux ; Humans ; lower esophageal sphincter ; Male ; Manometry ; Middle Aged ; Motilin - agonists ; motilin agonist ; Piperazines - pharmacology ; Piperidines - pharmacology ; Young Adult</subject><ispartof>Neurogastroenterology and motility, 2015-11, Vol.27 (11), p.1629-1637</ispartof><rights>2015 John Wiley & Sons Ltd</rights><rights>2015 John Wiley & Sons Ltd.</rights><rights>Copyright © 2015 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4233-69ea7caf21fd109748de886db3f5ad63374e07cc7cfcb6a5f9bb47f0feb4cf813</citedby><cites>FETCH-LOGICAL-c4233-69ea7caf21fd109748de886db3f5ad63374e07cc7cfcb6a5f9bb47f0feb4cf813</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%2Fnmo.12663$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fnmo.12663$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,1427,27903,27904,45553,45554,46388,46812</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26348542$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hobson, R.</creatorcontrib><creatorcontrib>Farmer, A. D.</creatorcontrib><creatorcontrib>Dewit, O. E.</creatorcontrib><creatorcontrib>O'Donnell, M.</creatorcontrib><creatorcontrib>Hacquoil, K.</creatorcontrib><creatorcontrib>Robertson, D.</creatorcontrib><creatorcontrib>Barton, M. E.</creatorcontrib><creatorcontrib>Dukes, G. E.</creatorcontrib><title>The effects of camicinal, a novel motilin agonist, on gastro‐esophageal function in healthy humans—a randomized placebo controlled trial</title><title>Neurogastroenterology and motility</title><addtitle>Neurogastroenterol Motil</addtitle><description>Background
A proportion of patients with foregut dysmotility fail to respond to standard interventions. Motilin agonists may be beneficial in this group. We aimed to determine the effect of camicinal, a novel motilin agonist, on gastrointestinal physiology in healthy volunteers.
Methods
Healthy male subjects were randomly assigned to receive a single dose of 125 mg camicinal or placebo in a double‐blind cross‐over design. Esophageal function and reflux indices were assessed using high‐resolution manometry (pre and 1.5‐h post dose) and 24‐h ambulatory multichannel intraluminal impedance/pH. After a standardized meal, subjects ingested a wireless motility capsule from which compartmental transit times and motility indices were derived. Subjects were restudied with the alternate intervention after 7 days.
Key Results
The study subjects (12 male, mean age 47.4 years, range 22–55) tolerated the drug well, except one who exhibited mild abdominal pain on both placebo and camicinal. In comparison to placebo, gastric emptying time (GET) was accelerated following camicinal (−115.4 min, 95% confidence interval −194.4, −36.4, p = 0.009). No effect was demonstrable on esophageal function, small bowel, colonic, or whole bowel transit times and motility indices. With camicinal, as part of a post hoc analysis, there was a trend association between the percentage reduction in GET and total number of acidic reflux events (r = 0.56, p = 0.09).
Conclusions & Inferences
Camicinal decreases GET and was generally well‐tolerated. In health, the direct effects of camicinal are on accelerating GET with a potential secondary benefit of reducing reflux events, which warrant further exploration in patient cohorts.
Camicinal, a novel motilin agonist, accelerates gastric emptying but has no discernable effect on esophageal function, small bowel, colonic, or whole gut transit times/motility indices in healthy humans.
View the podcast on this paper at the following sites:iTunes: https://itunes.apple.com/dk/podcast/neurogastroenterology-motility/id1045893519Youtube: https://youtu.be/DcjApg3j8yU</description><subject>Adult</subject><subject>Capsule Endoscopy</subject><subject>Cross-Over Studies</subject><subject>Double-Blind Method</subject><subject>Esophagogastric Junction - drug effects</subject><subject>Gastric Emptying - drug effects</subject><subject>Gastrointestinal Agents - pharmacology</subject><subject>gastro‐esophageal reflux</subject><subject>Humans</subject><subject>lower esophageal sphincter</subject><subject>Male</subject><subject>Manometry</subject><subject>Middle Aged</subject><subject>Motilin - agonists</subject><subject>motilin agonist</subject><subject>Piperazines - pharmacology</subject><subject>Piperidines - pharmacology</subject><subject>Young Adult</subject><issn>1350-1925</issn><issn>1365-2982</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp10b1u1TAUB_AIgWgpDLwAssQCUtP6K04yoqp8SIUuZY5OnOMbV459sRPQ7dQHYGDgCfsk-JLCgIQXW8c__YfzL4rnjJ6wfE79FE4YV0o8KA6ZUFXJ24Y_3L8rWrKWVwfFk5SuKaWKS_W4OOBKyKaS_LD4fjUiQWNQz4kEQzRMVlsP7pgA8eErOjKF2TrrCWyCt2k-JsGTDaQ5hrvbH5jCdoQNgiNm8Xq2-TPbMQ_mcUfGZQKf7m5_AonghzDZGxzI1oHGPhAdfE5xLo_maME9LR4ZcAmf3d9Hxee351dn78uLy3cfzt5clFpyIUrVItQaDGdmYLStZTNg06ihF6aCQQlRS6S11rU2uldQmbbvZW2owV5q0zBxVLxac7cxfFkwzd1kk0bnwGNYUsdqXret5GpPX_5Dr8MS835WJZRsmjar16vSMaQU0XTbaCeIu47Rbl9RlyvqfleU7Yv7xKWfcPgr_3SSwekKvlmHu_8ndZ8-Xq6RvwCz9J-r</recordid><startdate>201511</startdate><enddate>201511</enddate><creator>Hobson, R.</creator><creator>Farmer, A. D.</creator><creator>Dewit, O. E.</creator><creator>O'Donnell, M.</creator><creator>Hacquoil, K.</creator><creator>Robertson, D.</creator><creator>Barton, M. E.</creator><creator>Dukes, G. E.</creator><general>Wiley Subscription Services, Inc</general><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>7TK</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201511</creationdate><title>The effects of camicinal, a novel motilin agonist, on gastro‐esophageal function in healthy humans—a randomized placebo controlled trial</title><author>Hobson, R. ; Farmer, A. D. ; Dewit, O. E. ; O'Donnell, M. ; Hacquoil, K. ; Robertson, D. ; Barton, M. E. ; Dukes, G. E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4233-69ea7caf21fd109748de886db3f5ad63374e07cc7cfcb6a5f9bb47f0feb4cf813</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Capsule Endoscopy</topic><topic>Cross-Over Studies</topic><topic>Double-Blind Method</topic><topic>Esophagogastric Junction - drug effects</topic><topic>Gastric Emptying - drug effects</topic><topic>Gastrointestinal Agents - pharmacology</topic><topic>gastro‐esophageal reflux</topic><topic>Humans</topic><topic>lower esophageal sphincter</topic><topic>Male</topic><topic>Manometry</topic><topic>Middle Aged</topic><topic>Motilin - agonists</topic><topic>motilin agonist</topic><topic>Piperazines - pharmacology</topic><topic>Piperidines - pharmacology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hobson, R.</creatorcontrib><creatorcontrib>Farmer, A. D.</creatorcontrib><creatorcontrib>Dewit, O. E.</creatorcontrib><creatorcontrib>O'Donnell, M.</creatorcontrib><creatorcontrib>Hacquoil, K.</creatorcontrib><creatorcontrib>Robertson, D.</creatorcontrib><creatorcontrib>Barton, M. E.</creatorcontrib><creatorcontrib>Dukes, G. E.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Neurogastroenterology and motility</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hobson, R.</au><au>Farmer, A. D.</au><au>Dewit, O. E.</au><au>O'Donnell, M.</au><au>Hacquoil, K.</au><au>Robertson, D.</au><au>Barton, M. E.</au><au>Dukes, G. E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The effects of camicinal, a novel motilin agonist, on gastro‐esophageal function in healthy humans—a randomized placebo controlled trial</atitle><jtitle>Neurogastroenterology and motility</jtitle><addtitle>Neurogastroenterol Motil</addtitle><date>2015-11</date><risdate>2015</risdate><volume>27</volume><issue>11</issue><spage>1629</spage><epage>1637</epage><pages>1629-1637</pages><issn>1350-1925</issn><eissn>1365-2982</eissn><abstract>Background
A proportion of patients with foregut dysmotility fail to respond to standard interventions. Motilin agonists may be beneficial in this group. We aimed to determine the effect of camicinal, a novel motilin agonist, on gastrointestinal physiology in healthy volunteers.
Methods
Healthy male subjects were randomly assigned to receive a single dose of 125 mg camicinal or placebo in a double‐blind cross‐over design. Esophageal function and reflux indices were assessed using high‐resolution manometry (pre and 1.5‐h post dose) and 24‐h ambulatory multichannel intraluminal impedance/pH. After a standardized meal, subjects ingested a wireless motility capsule from which compartmental transit times and motility indices were derived. Subjects were restudied with the alternate intervention after 7 days.
Key Results
The study subjects (12 male, mean age 47.4 years, range 22–55) tolerated the drug well, except one who exhibited mild abdominal pain on both placebo and camicinal. In comparison to placebo, gastric emptying time (GET) was accelerated following camicinal (−115.4 min, 95% confidence interval −194.4, −36.4, p = 0.009). No effect was demonstrable on esophageal function, small bowel, colonic, or whole bowel transit times and motility indices. With camicinal, as part of a post hoc analysis, there was a trend association between the percentage reduction in GET and total number of acidic reflux events (r = 0.56, p = 0.09).
Conclusions & Inferences
Camicinal decreases GET and was generally well‐tolerated. In health, the direct effects of camicinal are on accelerating GET with a potential secondary benefit of reducing reflux events, which warrant further exploration in patient cohorts.
Camicinal, a novel motilin agonist, accelerates gastric emptying but has no discernable effect on esophageal function, small bowel, colonic, or whole gut transit times/motility indices in healthy humans.
View the podcast on this paper at the following sites:iTunes: https://itunes.apple.com/dk/podcast/neurogastroenterology-motility/id1045893519Youtube: https://youtu.be/DcjApg3j8yU</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>26348542</pmid><doi>10.1111/nmo.12663</doi><tpages>9</tpages></addata></record> |
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| subjects | Adult Capsule Endoscopy Cross-Over Studies Double-Blind Method Esophagogastric Junction - drug effects Gastric Emptying - drug effects Gastrointestinal Agents - pharmacology gastro‐esophageal reflux Humans lower esophageal sphincter Male Manometry Middle Aged Motilin - agonists motilin agonist Piperazines - pharmacology Piperidines - pharmacology Young Adult |
| title | The effects of camicinal, a novel motilin agonist, on gastro‐esophageal function in healthy humans—a randomized placebo controlled trial |
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