A prospective, randomized, double-blind, parallel group, placebo-controlled, single-dose study comparing the efficacy and safety of Extra Strength BAYER Aspirin, TYLENOL with Codeine #3, and placebo in subjects with dental pain.

The efficacy and safety of a single dose of two Extra Strength BAYER Aspirin Caplets (each containing aspirin 500 mg) was compared with one TYLENOL with Codeine #3 Tablet (containing acetaminophen 300 mg plus codeine phosphate 30 mg) or placebo in the treatment of subjects with acute postsurgical de...

Descripción completa

Detalles Bibliográficos
Publicado en:Journal of Applied Research Vol. 1; no. 2; pp. 110 - 118
Autores principales: MacEachern L, Fricke J, Sorrentino J, Quiring J, Garreffa S, Plaza D, Koslo R
Formato: clinical trial research tables/charts Journal Article
Publicado: Therapeutic Solutions LLC 2001 Fall
Acceso en línea:Ver este registro en EBSCOhost
fields @attributes:
  recordID: 1
pdfLink:
plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=106912395&site=ehost-live
header:
  @attributes:
    shortDbName: ccm
    uiTerm: 106912395
    longDbName: CINAHL Complete
    uiTag: AN
  controlInfo:
    bkinfo:
    dissinfo:
    jinfo:
      jid:
        1537064X
        I4L
      jtl: Journal of Applied Research
      issn: 1537064X
      maglogo: N
    pubinfo:
      dt: 2001 Fall
      vid: 1
      iid: 2
      pid: 13467
      pub: Therapeutic Solutions LLC
      place: Newtown, Pennsylvania
    artinfo:
      ui:
        106912395
        106912395
        2002039138
        106912395
      ppf: 110
      ppct: 8
      formats:
      tig:
        atl: A prospective, randomized, double-blind, parallel group, placebo-controlled, single-dose study comparing the efficacy and safety of Extra Strength BAYER Aspirin, TYLENOL with Codeine #3, and placebo in subjects with dental pain.
      aug:
        au:
          MacEachern L
          Fricke J
          Sorrentino J
          Quiring J
          Garreffa S
          Plaza D
          Koslo R
        affil: Bayer Corporation, Consumer Care Division, Morristown, NJ 07962
      sug:
        subj:
          Aspirin Therapeutic Use
          Postoperative Pain Drug Therapy
          Acetaminophen Therapeutic Use
          Codeine Therapeutic Use
          Pain Measurement
          Adult
          Middle Age
          Analysis of Variance
          Mantel-Haenszel Test
          Double-Blind Studies
          Treatment Outcomes
          Placebos Therapeutic Use
          Fisher's Exact Test
          Tooth, Impacted Surgery
          Molar Surgery
          Funding Source
          Human
          Adult: 19-44 years
          Middle Aged: 45-64 years
      ab: The efficacy and safety of a single dose of two Extra Strength BAYER Aspirin Caplets (each containing aspirin 500 mg) was compared with one TYLENOL with Codeine #3 Tablet (containing acetaminophen 300 mg plus codeine phosphate 30 mg) or placebo in the treatment of subjects with acute postsurgical dental pain. One hundred twenty subjects who dosed with Extra Strength BAYER Aspirin and 121 subjects who dosed with TYLENOL with Codeine were compared with 61 subjects who dosed with placebo in this double-blind, randomized, parallel group, placebo-controlled, single-dose clinical trial. Qualified subjects who experienced moderate to severe pain following surgical extraction of two or more third molars were randomly allocated to receive two Extra Strength BAYER Aspirin Caplets, one TYLENOL with Codeine #3 Tablet, or placebo. At 30 minutes, 1, 2, 3, 4, 5, and 6 hours postdosing, subjects rated their pain intensity, pain relief, and whether the pain relief was meaningful compared to baseline. A significant treatment effect was observed favoring Extra Strength BAYER Aspirin over TYLENOL with Codeine for pain intensity difference (PID), peak PID, summed pain intensity difference (SPID), pain relief, total pain relief (TOTPAR), time to taking backup medication, and time to meaningful relief. Extra Strength BAYER Aspirin (1000 mg) was superior to one TYLENOL with Codeine #3 in treating moderate to severe dental pain. Both medications were well tolerated.
      pubtype: Academic Journal
      doctype:
        clinical trial
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
    refInfo:
    holdings:
      @attributes:
        islocal: N