A randomised, placebo-controlled trial comparing the effects of tapentadol and oxycodone on gastrointestinal and colonic transit in healthy humans

I. D. Jeong, Michael Camilleri, A. Shin, J. Iturrino, A. Boldingh, I. Busciglio, D. Burton, M. Ryks, D. Rhoten, A. R. Zinsmeister

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Background: Tapentadol is a mu-opioid receptor agonist and norepinephrine reuptake inhibitor. In clinical trials, tapentadol provided somatic pain relief comparable to muopioids such as oxycodone, with significantly less gastrointestinal adverse effects. The acute effects of tapentadol on gastrointestinal and colonic transit are unclear. Aim: To compare acute effects of oral tapentadol and oxycodone on gastric, small bowel and colonic transit of solids in 38 healthy human subjects. Methods: In a randomised, parallel-group, double-blind, placebo-controlled study of the effects of identical-appearing tapentadol immediate release (IR), 75 mg t.d.s., or oxycodone IR, 5 mg t.d.s., for 48 h, we measured gastric (GE), small bowel (SBT measured as colonic filling at 6 h) and colonic transit by validated scintigraphy. Drug was commenced on the evening before the start of the transit test. The primary endpoints were overall colonic transit (geometric centre, GC) at 24 h and GE half-time (t1/2). ANCOVA of transit data included gender or BMI as covariates. Adverse effects were summarised. Results: At the doses tested, oxycodone and tapentadol significantly delayed GE t1/2 and SBT, but not overall colonic transit, compared to placebo. Transit profiles in all regions were not significantly different between oxycodone and tapentadol at the doses tested. Both oxycodone and tapentadol were associated with nausea and central effects attributable to central opiate effects. Conclusions: Tapentadol significantly delayed gastric emptying t1/2 and small bowel transit, similar to oxycodone. These data suggest that acute administration of tapentadol may not have significant advantages over standard mu-opioids, in terms of the potential to avoid upper gastrointestinal motor dysfunction.

Original languageEnglish (US)
Pages (from-to)1088-1096
Number of pages9
JournalAlimentary Pharmacology and Therapeutics
Volume35
Issue number9
DOIs
StatePublished - 2012

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Gastrointestinal Transit
Oxycodone
Randomized Controlled Trials
Placebos
Opiate Alkaloids
Stomach
tapentadol
Nociceptive Pain
mu Opioid Receptor
Gastric Emptying
Radionuclide Imaging
Nausea
Opioid Analgesics
Norepinephrine
Healthy Volunteers
Clinical Trials

ASJC Scopus subject areas

  • Pharmacology (medical)

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A randomised, placebo-controlled trial comparing the effects of tapentadol and oxycodone on gastrointestinal and colonic transit in healthy humans. / Jeong, I. D.; Camilleri, Michael; Shin, A.; Iturrino, J.; Boldingh, A.; Busciglio, I.; Burton, D.; Ryks, M.; Rhoten, D.; Zinsmeister, A. R.

In: Alimentary Pharmacology and Therapeutics, Vol. 35, No. 9, 2012, p. 1088-1096.

Research output: Contribution to journalArticle

Jeong, I. D. ; Camilleri, Michael ; Shin, A. ; Iturrino, J. ; Boldingh, A. ; Busciglio, I. ; Burton, D. ; Ryks, M. ; Rhoten, D. ; Zinsmeister, A. R. / A randomised, placebo-controlled trial comparing the effects of tapentadol and oxycodone on gastrointestinal and colonic transit in healthy humans. In: Alimentary Pharmacology and Therapeutics. 2012 ; Vol. 35, No. 9. pp. 1088-1096.
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T1 - A randomised, placebo-controlled trial comparing the effects of tapentadol and oxycodone on gastrointestinal and colonic transit in healthy humans

AU - Jeong, I. D.

AU - Camilleri, Michael

AU - Shin, A.

AU - Iturrino, J.

AU - Boldingh, A.

AU - Busciglio, I.

AU - Burton, D.

AU - Ryks, M.

AU - Rhoten, D.

AU - Zinsmeister, A. R.

PY - 2012

Y1 - 2012

N2 - Background: Tapentadol is a mu-opioid receptor agonist and norepinephrine reuptake inhibitor. In clinical trials, tapentadol provided somatic pain relief comparable to muopioids such as oxycodone, with significantly less gastrointestinal adverse effects. The acute effects of tapentadol on gastrointestinal and colonic transit are unclear. Aim: To compare acute effects of oral tapentadol and oxycodone on gastric, small bowel and colonic transit of solids in 38 healthy human subjects. Methods: In a randomised, parallel-group, double-blind, placebo-controlled study of the effects of identical-appearing tapentadol immediate release (IR), 75 mg t.d.s., or oxycodone IR, 5 mg t.d.s., for 48 h, we measured gastric (GE), small bowel (SBT measured as colonic filling at 6 h) and colonic transit by validated scintigraphy. Drug was commenced on the evening before the start of the transit test. The primary endpoints were overall colonic transit (geometric centre, GC) at 24 h and GE half-time (t1/2). ANCOVA of transit data included gender or BMI as covariates. Adverse effects were summarised. Results: At the doses tested, oxycodone and tapentadol significantly delayed GE t1/2 and SBT, but not overall colonic transit, compared to placebo. Transit profiles in all regions were not significantly different between oxycodone and tapentadol at the doses tested. Both oxycodone and tapentadol were associated with nausea and central effects attributable to central opiate effects. Conclusions: Tapentadol significantly delayed gastric emptying t1/2 and small bowel transit, similar to oxycodone. These data suggest that acute administration of tapentadol may not have significant advantages over standard mu-opioids, in terms of the potential to avoid upper gastrointestinal motor dysfunction.

AB - Background: Tapentadol is a mu-opioid receptor agonist and norepinephrine reuptake inhibitor. In clinical trials, tapentadol provided somatic pain relief comparable to muopioids such as oxycodone, with significantly less gastrointestinal adverse effects. The acute effects of tapentadol on gastrointestinal and colonic transit are unclear. Aim: To compare acute effects of oral tapentadol and oxycodone on gastric, small bowel and colonic transit of solids in 38 healthy human subjects. Methods: In a randomised, parallel-group, double-blind, placebo-controlled study of the effects of identical-appearing tapentadol immediate release (IR), 75 mg t.d.s., or oxycodone IR, 5 mg t.d.s., for 48 h, we measured gastric (GE), small bowel (SBT measured as colonic filling at 6 h) and colonic transit by validated scintigraphy. Drug was commenced on the evening before the start of the transit test. The primary endpoints were overall colonic transit (geometric centre, GC) at 24 h and GE half-time (t1/2). ANCOVA of transit data included gender or BMI as covariates. Adverse effects were summarised. Results: At the doses tested, oxycodone and tapentadol significantly delayed GE t1/2 and SBT, but not overall colonic transit, compared to placebo. Transit profiles in all regions were not significantly different between oxycodone and tapentadol at the doses tested. Both oxycodone and tapentadol were associated with nausea and central effects attributable to central opiate effects. Conclusions: Tapentadol significantly delayed gastric emptying t1/2 and small bowel transit, similar to oxycodone. These data suggest that acute administration of tapentadol may not have significant advantages over standard mu-opioids, in terms of the potential to avoid upper gastrointestinal motor dysfunction.

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