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A randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain

ABSTRACT Objective: This study evaluated tapentadol immediate release (IR) for pain relief following orthopedic bunionectomy surgery. Methods: This randomized, double-blind, placebo- and active-controlled, phase III study included patients with moderate-to-severe pain following bunionectomy. Randomi... Full description

Journal Title: Current medical research and opinion 2009-03, Vol.25 (3), p.765-776
Main Author: Daniels, Stephen E
Other Authors: Upmalis, David , Okamoto, Akiko , Lange, Claudia , Häeussler, Jüergen
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Informa UK Ltd
ID: ISSN: 0300-7995
Link: https://www.ncbi.nlm.nih.gov/pubmed/19203298
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title: A randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain
format: Article
creator:
  • Daniels, Stephen E
  • Upmalis, David
  • Okamoto, Akiko
  • Lange, Claudia
  • Häeussler, Jüergen
subjects:
  • Adult
  • Analgesics
  • Bunion
  • Double-Blind Method
  • Humans
  • Middle Aged
  • Mu-opioid receptors
  • Orthopedics
  • Oxycodone - administration & dosage
  • Oxycodone - therapeutic use
  • Pain, Postoperative - drug therapy
  • Phenols - administration & dosage
  • Phenols - therapeutic use
  • Placebos
  • Postoperative pain
  • Surgery
  • Tapentadol
ispartof: Current medical research and opinion, 2009-03, Vol.25 (3), p.765-776
description: ABSTRACT Objective: This study evaluated tapentadol immediate release (IR) for pain relief following orthopedic bunionectomy surgery. Methods: This randomized, double-blind, placebo- and active-controlled, phase III study included patients with moderate-to-severe pain following bunionectomy. Randomized patients (N = 603) received tapentadol IR 50, 75, or 100 mg; oxycodone HCl IR 15 mg; or placebo orally every 4-6 hours over a 72-hour period following bunionectomy. The primary endpoint was the sum of pain intensity difference (SPID) over 48 hours. Secondary endpoints included SPID over 12, 24, and 72 hours; total pain relief, and sum of total pain relief and sum of pain intensity difference (SPRID) over 12, 24, 48, and 72 hours; use of rescue medication; patient global impression of change; and onset of action assessment. Possible limitations of this study were that the intense dose monitoring and thorough nursing care were unlikely to represent actual use situations and could introduce similar bias across all treatment groups. Clinical trial registration: NCT00364247. Results: Mean SPID48 values were significantly higher for tapentadol IR (50, 75, and 100 mg) and oxycodone HCl IR 15 mg compared with placebo (all p ≤ 0.001). The overall incidence of adverse events was 70% for tapentadol IR 50 mg, 75% for tapentadol IR 75 mg, 85% for tapentadol IR 100 mg, 87% for oxycodone HCl IR 15 mg, and 41% for placebo. Post hoc analyses showed that tapentadol IR 100 mg and oxycodone HCl IR 15 mg provided equivalent analgesia, yet tapentadol IR 100 mg had a significantly lower incidence of nausea and/or vomiting (53% vs 70%, respectively, nominal p = 0.007). Conclusions: Multiple doses of tapentadol IR (50, 75, and 100 mg) significantly relieve acute pain after orthopedic surgery compared with placebo. These data suggest that at doses providing comparable efficacy, tapentadol IR 100 mg has improved gastrointestinal tolerability compared with oxycodone HCl IR 15 mg.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0300-7995
fulltext: fulltext
issn:
  • 0300-7995
  • 1473-4877
url: Link


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titleA randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain
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creatorDaniels, Stephen E ; Upmalis, David ; Okamoto, Akiko ; Lange, Claudia ; Häeussler, Jüergen
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descriptionABSTRACT Objective: This study evaluated tapentadol immediate release (IR) for pain relief following orthopedic bunionectomy surgery. Methods: This randomized, double-blind, placebo- and active-controlled, phase III study included patients with moderate-to-severe pain following bunionectomy. Randomized patients (N = 603) received tapentadol IR 50, 75, or 100 mg; oxycodone HCl IR 15 mg; or placebo orally every 4-6 hours over a 72-hour period following bunionectomy. The primary endpoint was the sum of pain intensity difference (SPID) over 48 hours. Secondary endpoints included SPID over 12, 24, and 72 hours; total pain relief, and sum of total pain relief and sum of pain intensity difference (SPRID) over 12, 24, 48, and 72 hours; use of rescue medication; patient global impression of change; and onset of action assessment. Possible limitations of this study were that the intense dose monitoring and thorough nursing care were unlikely to represent actual use situations and could introduce similar bias across all treatment groups. Clinical trial registration: NCT00364247. Results: Mean SPID48 values were significantly higher for tapentadol IR (50, 75, and 100 mg) and oxycodone HCl IR 15 mg compared with placebo (all p ≤ 0.001). The overall incidence of adverse events was 70% for tapentadol IR 50 mg, 75% for tapentadol IR 75 mg, 85% for tapentadol IR 100 mg, 87% for oxycodone HCl IR 15 mg, and 41% for placebo. Post hoc analyses showed that tapentadol IR 100 mg and oxycodone HCl IR 15 mg provided equivalent analgesia, yet tapentadol IR 100 mg had a significantly lower incidence of nausea and/or vomiting (53% vs 70%, respectively, nominal p = 0.007). Conclusions: Multiple doses of tapentadol IR (50, 75, and 100 mg) significantly relieve acute pain after orthopedic surgery compared with placebo. These data suggest that at doses providing comparable efficacy, tapentadol IR 100 mg has improved gastrointestinal tolerability compared with oxycodone HCl IR 15 mg.
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subjectAdult ; Analgesics ; Bunion ; Double-Blind Method ; Humans ; Middle Aged ; Mu-opioid receptors ; Orthopedics ; Oxycodone - administration & dosage ; Oxycodone - therapeutic use ; Pain, Postoperative - drug therapy ; Phenols - administration & dosage ; Phenols - therapeutic use ; Placebos ; Postoperative pain ; Surgery ; Tapentadol
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descriptionABSTRACT Objective: This study evaluated tapentadol immediate release (IR) for pain relief following orthopedic bunionectomy surgery. Methods: This randomized, double-blind, placebo- and active-controlled, phase III study included patients with moderate-to-severe pain following bunionectomy. Randomized patients (N = 603) received tapentadol IR 50, 75, or 100 mg; oxycodone HCl IR 15 mg; or placebo orally every 4-6 hours over a 72-hour period following bunionectomy. The primary endpoint was the sum of pain intensity difference (SPID) over 48 hours. Secondary endpoints included SPID over 12, 24, and 72 hours; total pain relief, and sum of total pain relief and sum of pain intensity difference (SPRID) over 12, 24, 48, and 72 hours; use of rescue medication; patient global impression of change; and onset of action assessment. Possible limitations of this study were that the intense dose monitoring and thorough nursing care were unlikely to represent actual use situations and could introduce similar bias across all treatment groups. Clinical trial registration: NCT00364247. Results: Mean SPID48 values were significantly higher for tapentadol IR (50, 75, and 100 mg) and oxycodone HCl IR 15 mg compared with placebo (all p ≤ 0.001). The overall incidence of adverse events was 70% for tapentadol IR 50 mg, 75% for tapentadol IR 75 mg, 85% for tapentadol IR 100 mg, 87% for oxycodone HCl IR 15 mg, and 41% for placebo. Post hoc analyses showed that tapentadol IR 100 mg and oxycodone HCl IR 15 mg provided equivalent analgesia, yet tapentadol IR 100 mg had a significantly lower incidence of nausea and/or vomiting (53% vs 70%, respectively, nominal p = 0.007). Conclusions: Multiple doses of tapentadol IR (50, 75, and 100 mg) significantly relieve acute pain after orthopedic surgery compared with placebo. These data suggest that at doses providing comparable efficacy, tapentadol IR 100 mg has improved gastrointestinal tolerability compared with oxycodone HCl IR 15 mg.
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titleA randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain
authorDaniels, Stephen E ; Upmalis, David ; Okamoto, Akiko ; Lange, Claudia ; Häeussler, Jüergen
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abstractABSTRACT Objective: This study evaluated tapentadol immediate release (IR) for pain relief following orthopedic bunionectomy surgery. Methods: This randomized, double-blind, placebo- and active-controlled, phase III study included patients with moderate-to-severe pain following bunionectomy. Randomized patients (N = 603) received tapentadol IR 50, 75, or 100 mg; oxycodone HCl IR 15 mg; or placebo orally every 4-6 hours over a 72-hour period following bunionectomy. The primary endpoint was the sum of pain intensity difference (SPID) over 48 hours. Secondary endpoints included SPID over 12, 24, and 72 hours; total pain relief, and sum of total pain relief and sum of pain intensity difference (SPRID) over 12, 24, 48, and 72 hours; use of rescue medication; patient global impression of change; and onset of action assessment. Possible limitations of this study were that the intense dose monitoring and thorough nursing care were unlikely to represent actual use situations and could introduce similar bias across all treatment groups. Clinical trial registration: NCT00364247. Results: Mean SPID48 values were significantly higher for tapentadol IR (50, 75, and 100 mg) and oxycodone HCl IR 15 mg compared with placebo (all p ≤ 0.001). The overall incidence of adverse events was 70% for tapentadol IR 50 mg, 75% for tapentadol IR 75 mg, 85% for tapentadol IR 100 mg, 87% for oxycodone HCl IR 15 mg, and 41% for placebo. Post hoc analyses showed that tapentadol IR 100 mg and oxycodone HCl IR 15 mg provided equivalent analgesia, yet tapentadol IR 100 mg had a significantly lower incidence of nausea and/or vomiting (53% vs 70%, respectively, nominal p = 0.007). Conclusions: Multiple doses of tapentadol IR (50, 75, and 100 mg) significantly relieve acute pain after orthopedic surgery compared with placebo. These data suggest that at doses providing comparable efficacy, tapentadol IR 100 mg has improved gastrointestinal tolerability compared with oxycodone HCl IR 15 mg.
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