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...
| Publicado en: | Journal of Applied Research Vol. 1; no. 2; pp. 110 - 118 |
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| Autores principales: | , , , , , , |
| Formato: | clinical trial research tables/charts Journal Article |
| Publicado: |
Therapeutic Solutions LLC
2001 Fall
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| 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 |
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