Publications by authors named "Bernard Schachtel"

Objectives: To determine the efficacy of flurbiprofen 8.75 mg lozenges for patients with laboratory-confirmed streptococcal pharyngitis both before and concomitant with antibiotics.

Methods: This post hoc analysis comprised adult participants from 2 earlier randomized, double-blind, placebo-controlled studies evaluating the analgesic efficacy of flurbiprofen 8.

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The Qualities of Sore Throat Index (QuaSTI) assesses the status of patient-reported pharyngeal pain. One study used QuaSTI in isolation; a separate study used QuaSTI plus the Sore Throat Scale (STS). Both studies also used a Sore Throat Pain Intensity Scale (STPIS).

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Objectives: To evaluate the prevention of opioid-induced nausea and vomiting (OINV) and the relief of moderate to severe acute pain by CL-108, a novel drug combining a low-dose antiemetic (rapid-release promethazine 12.5 mg) with hydrocodone 7.5 mg/acetaminophen 325 mg (HC/APAP) was used.

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Background: The double stopwatch (DSW) method for determining the onset of analgesic activity has been implemented extensively by investigators studying orally administered drugs.

Objective: The aim of this randomised, placebo-controlled trial was to use the DSW method to determine the time to onset of analgesia of a single dose of a topically administered non-steroidal anti-inflammatory drug, flurbiprofen 8.75 mg lozenge.

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Aim: Patients with pharyngitis often describe various sensory, affective and evaluative pain qualities. Using an 11-word/phrase index, the Qualities of Sore Throat Index (QuaSTI), we characterized throat symptoms and evaluated changes in a randomized controlled trial (NCT01986361).

Materials & Methods: Patients received a single flurbiprofen 8.

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Clinical trials to test the safety and efficacy of analgesics across all pediatric age cohorts are needed to avoid inappropriate extrapolation of adult data to children. However, the selection of acute pain models and trial design attributes to maximize assay sensitivity, by pediatric age cohort, remains problematic. Acute pain models used for drug treatment trials in adults are not directly applicable to the pediatric age cohorts-neonates, infants, toddlers, children, and adolescents.

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Objective: With the increasing societal awareness of the prevalence and impact of acute pain, there is a need to develop an acute pain classification system that both reflects contemporary mechanistic insights and helps guide future research and treatment. Existing classifications of acute pain conditions are limiting, with a predominant focus on the sensory experience (eg, pain intensity) and pharmacologic consumption. Consequently, there is a need to more broadly characterize and classify the multidimensional experience of acute pain.

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Objective: With the increasing societal awareness of the prevalence and impact of acute pain, there is a need to develop an acute pain classification system that both reflects contemporary mechanistic insights and helps guide future research and treatment. Existing classifications of acute pain conditions are limiting, with a predominant focus on the sensory experience (e.g.

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Aim: This study assessed multiple doses of flurbiprofen 8.75 mg lozenges for the relief of three prominent symptoms of acute pharyngitis: pain intensity (primary end point), difficulty swallowing and swollen throat.

Patients & Methods: A total of 204 patients (102 in each group) with confirmed pharyngitis (onset ≤4 days) were randomly assigned to take up to five flurbiprofen or placebo lozenges every 3-6 h, for 7 days.

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Objective: Sore throat is often over-treated with antibiotics, therefore there is a need for non-antibiotic treatments that provide effective relief. From the patient's point of view, symptoms of pharyngeal inflammation such as a "swollen" and "inflamed" throat are often considered the most bothersome; so, a non-steroidal anti-inflammatory drug could be an appropriate treatment. We investigated the efficacy and safety of flurbiprofen 8.

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The Publisher regrets that this abstract is an accidental duplication of abstract (431), also published in the 2016 American Pain Society Scientific Meeting abstracts supplement: J Pain 17:S82, 2016, http://dx.doi.org/10.

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Background: The sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials. The model used here was designed to study the multiple-dose safety and efficacy of lozenges containing flurbiprofen at 8.75 mg.

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A new onset-of-action model was utilized to distinguish the pharmacologic activity of flurbiprofen 8.75mg delivered in a lozenge from the demulcent effect of the lozenge base. In a randomized, double-blind, placebo-controlled trial, patients with sore throat rated pain on a Sore Throat Pain Intensity Scale before taking one flurbiprofen or placebo lozenge and at frequent (2-minute) intervals over the first hour after treatment.

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Unlabelled: The sore throat pain model was used to evaluate single-dose effects of celecoxib 50 and 100 mg over 6 hours in the treatment of acute pharyngeal pain. Multiple-dose effects of 50-mg bid and 100 mg followed by 50 mg over 6 to 24 hours were also evaluated. Under double-blind, randomized, placebo-controlled conditions, 269 adults with confirmed acute pharyngitis rated throat pain intensity, throat soreness, difficulty swallowing, and sore throat pain relief over 24 hours.

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To determine acute analgesia by acetylsalicylic acid (ASA) when combined with pseudoephedrine (PSE) in patients with upper respiratory tract infection (URTI), we used the sore throat pain model to measure single-dose effects of ASA 500 mg/PSE 30 mg, ASA 1000 mg/PSE 60 mg, and acetaminophen (APAP) 1000 mg/PSE 60 mg (serving as a positive control). Under double-blind, randomized, placebo-controlled conditions, 640 adult patients with confirmed acute pharyngitis and rhinosinusitis associated with URTI rated throat pain intensity and relief at intervals over 6 hours. Efficacy was demonstrated for both doses of ASA/PSE compared with placebo for all end points, including total pain relief and summed pain intensity differences, beginning at 20 minutes on both scales (all P < .

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The sore throat pain model was employed in this randomized, placebo-controlled trial to examine the sensitivity of the model in testing the efficacy of valdecoxib as an acute analgesic drug. Changes were made to the study design by employing a different diagnostic index for tonsillo-pharyngitis, a different rating scale (derived from Lasagna's pain thermometer), and alternative analyses, individual responder rates. Under double-blind conditions, 197 patients with painful pharyngitis were randomly allocated to valdecoxib 20 mg bid (n = 65), valdecoxib 40 mg qd (n = 66), or placebo (n = 66) for 24 hours.

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Objective: The aim of this study was to determine the time to onset of pain relief from a single dose of a tablet formulation of paracetamol (acetaminophen) containing sodium bicarbonate (PSC).

Methods: A single oral dose of PSC or placebo was randomly administered to patients with acute sore throat under double-blind conditions. Patients rated their pain relief using a conventional categorical relief scale every 5 minutes during the first hour postdose to determine the time to onset of pain relief.

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Background And Aims: The Food and Drug Administration approval and subsequent launch of over-the-counter (OTC) omeprazole raises the question whether consumers would use OTC omeprazole appropriately in a "real world" setting.

Methods: A 3-month observational study was conducted in an OTC setting to determine whether consumers could (1) correctly self-select to use omeprazole for frequent heartburn, (2) comply with a product label that calls for 14 consecutive days of once-daily dosing, and (3) use more than 14 doses of medication only under the advice of a physician. Consumers were interviewed at 5 shopping malls in geographically distinct areas of the United States and asked whether they had heartburn.

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