PMID- 21231862
OWN - NLM
STAT- MEDLINE
DCOM- 20110614
LR  - 20220316
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 27
IP  - 3
DP  - 2011 Mar
TI  - Efficacy and safety of oxycodone HCl/niacin tablets for the treatment of 
      moderate-to-severe postoperative pain following bunionectomy surgery.
PG  - 593-603
LID - 10.1185/03007995.2010.548291 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of two dose strengths of oxycodone 
      hydrochloride (HCl)/niacin tablets * for the treatment of moderate-to-severe 
      postoperative pain following bunionectomy surgery. RESEARCH DESIGN AND METHODS: 
      Randomized, double-blind, placebo-controlled, US multicenter, repeat-dose study 
      (Clinicaltrials.gov: NCT00654069). A total of 606 patients aged >/=18 years with 
      moderate-to-severe pain post-bunionectomy were screened, and 405 patients were 
      randomized to receive placebo, 2 x 5/30 mg oxycodone HCl/niacin tablets, or 
      2 x 7.5/30 mg oxycodone HCl/niacin tablets administered every 6 hours for 48 
      hours. Ketorolac tromethamine was available as rescue medication. MAIN OUTCOME 
      MEASURES: Primary efficacy endpoint was the sum of pain-intensity difference 
      scores during the 48 hours (SPID(48)) following the initial dose of study drug. 
      Secondary efficacy endpoints included a responder analysis and use of rescue 
      medication. Safety evaluations included adverse events (AEs), vital signs, and 
      clinical laboratory assessments. RESULTS: Both doses of oxycodone HCl/niacin 
      tablets demonstrated superior reductions in pain intensity compared with placebo 
      as evidenced by the SPID(48) (p < 0.0001 for both oxycodone HCl/niacin 
      2 x 5/30 mg and 2 x 7.5/30 mg). AEs were consistent with the known effects of 
      oxycodone HCl and niacin. Most AEs were mild or moderate in intensity, and no 
      serious AEs occurred. There were no discontinuations due to AEs in the placebo 
      group; 2/135 (1.5%) discontinued due to AEs in the 2 x 5/30 mg group and 4/134 
      (3.0%) in the 2 x 7.5/30 mg group. A limitation of this study was that there was 
      no active comparator arm. CONCLUSIONS: Oxycodone HCl/niacin tablets (5/30 mg and 
      7.5/30 mg) provide effective analgesia and are generally well tolerated in 
      patients with moderate-to-severe pain following bunionectomy surgery.
FAU - Daniels, Stephen E
AU  - Daniels SE
AD  - Premier Research Group, Austin, Texas 78705, USA. 
      Stephen.daniels@premier-research.com
FAU - Spivey, Ron J
AU  - Spivey RJ
FAU - Singla, Sonia
AU  - Singla S
FAU - Golf, Michael
AU  - Golf M
FAU - Clark, Francis J
AU  - Clark FJ
LA  - eng
SI  - ClinicalTrials.gov/NCT00654069
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110113
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Placebos)
RN  - 0 (Tablets)
RN  - 0 (Vasodilator Agents)
RN  - 2679MF687A (Niacin)
RN  - CD35PMG570 (Oxycodone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Algorithms
MH  - Analgesics, Opioid/administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Drug Therapy, Combination/adverse effects
MH  - Female
MH  - Hallux Valgus/drug therapy/*surgery
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Niacin/*administration & dosage/adverse effects
MH  - Orthopedics
MH  - Oxycodone/*administration & dosage/adverse effects
MH  - Pain, Postoperative/*drug therapy
MH  - Placebos
MH  - Severity of Illness Index
MH  - Tablets
MH  - Treatment Outcome
MH  - United States
MH  - Vasodilator Agents/administration & dosage/adverse effects
MH  - Young Adult
EDAT- 2011/01/15 06:00
MHDA- 2011/06/15 06:00
CRDT- 2011/01/15 06:00
PHST- 2011/01/15 06:00 [entrez]
PHST- 2011/01/15 06:00 [pubmed]
PHST- 2011/06/15 06:00 [medline]
AID - 10.1185/03007995.2010.548291 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2011 Mar;27(3):593-603. doi: 10.1185/03007995.2010.548291. 
      Epub 2011 Jan 13.