An Open Label, In-use Study to Assess the Warming Sensation, Acceptability and Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup Given as a 30 ml Single Dose in Subjects Suffering From Symptoms of an Upper Respiratory Tract Infection

This is an open label, in-use study to assess the warming sensation, acceptability and local tolerability of paracetamol 500 mg + pseudoephedrine 30 mg syrup, given as a single dose in subjects suffering from symptoms of an upper respiratory tract infection. The purpose is to evaluate the acceptability concerning a warming sensation effect and its potential benefit in the target population.
The primary objective is to assess the warming sensation caused by the excipient IFF flavor 316 282, in a syrup containing paracetamol 500 mg + pseudoephedrine 30 mg per 30 ml syrup. The syrup contains (0.15% w/v) warming flavor.
The Secondary Objectives are to assess subject acceptability of the syrup and the safety and tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal congestion associated with colds and flu symptoms such as pain, headache and/or fever. Subjects must have one or more symptoms per category:
mild to moderate body pain, headache, fever or sore throat
nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing Adolescents will be included in the study population

开始日期2012-05-01

申办/合作机构

Novartis AG

[+1]

NCT01576809 / Completed临床3期

An Open Label, In-use Study to Assess the Warming Sensation, Acceptability and Local Tolerability of Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Syrup Given as a 30 ml Single Dose in Subjects Suffering From Symptoms of an Upper Respiratory Tract Infection

This is an open label, in-use study to assess the warming sensation, acceptability and local tolerability of paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg syrup, given as a single dose in subjects suffering from symptoms of an upper respiratory tract infection. The purpose is to evaluate the acceptability concerning a warming sensation effect and its potential benefit in the target population.
The primary objective is to assess the warming sensation caused by the excipient IFF flavor 316 282, in a syrup containing paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup. The syrup contains (0.15% w/v) warming flavor.
The Secondary Objectives are to assess subject acceptability of the syrup and the safety and tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal congestion associated with colds and flu symptoms such as pain, headache and/or fever. Subjects must have one or more symptoms per category:
mild to moderate body pain, headache, fever or sore throat
nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing
productive cough Adolescents will be included in the study population

开始日期2012-03-01

申办/合作机构

Novartis AG

[+1]

EUCTR2007-004316-31-GB / Not yet recruiting临床4期

A randomised, double-blind, vehicle controlled, single centre, parallel group, comparative study of the efficacy of penciclovir 10 mg/g (1%) cream in preventing the appearance of classical lesions in recurrent cold sore sufferers. - Penciclovir 1% Cream Efficacy Study

开始日期2009-02-23

申办/合作机构

Novartis Consumer Health, Inc.

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2015-08-01·Journal of Pharmacy Practice

Symptomatic Overlap and Therapeutic Opportunities in Primary Headache

Review

作者: Patel, Ketu ; Garas, Sandy Yacoub ; Peterson, Andrew ; Cady, Roger ; Wenzel, Richard

Headache, a nearly universal experience, remains costly, disabling, and often suboptimally managed. The most common presentations in the United States are migraine, tension-type headache (TTH) and “sinus” headache, but their extensive symptomatic overlap suggests that these conditions can be approached as variations in the same underlying pathology and managed accordingly. We use case studies of patients with varying prior diagnoses (none, migraine, TTH, and sinus headache), as well as a 4-question diagnostic screening tool, to illustrate how pharmacists can use this conceptual framework to simplify identification, management, and referral of patients with primary headache conditions of uncertain etiology.

2014-11-01·Cephalalgia2区 · 医学

Results of a multicenter, double-blind, randomized, parallel-group, placebo-controlled, single-dose study comparing the fixed combination of acetaminophen, acetylsalicylic acid, and caffeine with ibuprofen for acute treatment of patients with severe migraine

2区 · 医学

Article

作者: Hagen, Martina ; Goldstein, Jerome ; Gold, Morris

Introduction In a multicenter, double-blind, randomized, parallel-group, placebo-controlled, single-dose study ( n = 1555), a fixed combination of acetaminophen 500 mg, acetylsalicylic acid 500 mg, and caffeine 130 mg (AAC) was compared with ibuprofen 400 mg (IB) and placebo (PLA) for acute treatment of migraine. Subjects and methods An exploratory post-hoc analysis compared AAC with IB and PLA in the subset of patients with severe pain at baseline ( n = 660). Results At most time points, AAC and IB relieved the pain and associated symptoms of severe migraine significantly better than PLA ( p ≤ 0.05). AAC was significantly superior to IB for pain relief at 45 minutes and at one, two, three, and four hours postdose ( p < 0.04); pain intensity difference from one hour through three hours ( p < 0.05); headache response at two hours ( p = 0.04); functional disability reduced to little or none at three hours ( p = 0.013); freedom from phonophobia at three hours ( p = 0.04) and photophobia at 15 minutes postdose ( p = 0.03); and use of rescue medication ( p = 0.018). AAC patients also reported meaningful pain relief 16 minutes faster than IB patients (132 minutes vs 148 minutes, p = 0.026). Conclusions In patients with severe baseline migraine pain, AAC and IB are significantly more effective than PLA, and AAC provides significantly faster and more effective pain relief than IB.

2011-10-01·Journal of International Medical Research4区 · 医学

Chronic Dietary Fiber Supplementation with Wheat Dextrin does not Inhibit Calcium and Magnesium Absorption in Premenopausal and Postmenopausal Women

4区 · 医学

ArticleOA

作者: Hospattankar, A ; Abrams, SA ; Heaney, RP ; Armas, LAG ; Rafferty, K

This placebo-controlled, randomized, crossover clinical study examined the effect of chronic wheat dextrin intake on calcium and magnesium absorption. Forty premenopausal and postmenopausal women (mean ± SD age 49.9 ± 9.8 years) consumed wheat dextrin or placebo (15 g/day) for 2 weeks prior to 45calcium (45Ca) and 26magnesium (26Mg) absorption testing. After a standardized breakfast, serial blood and urine samples were obtained. The mean ± SD area under the curve from 0 to 9 h for 45Ca specific activity was 0.81 ± 0.21 for wheat dextrin and 0.82 ± 0.22 for placebo, showing that wheat dextrin had no effect on calcium absorption. The mean ± SD percentage excess of 26Mg/24Mg was 7.8% ± 2.1% for wheat dextrin and 7.9% ± 2.6% for placebo, showing that wheat dextrin had no effect on magnesium absorption. In conclusion, chronic wheat dextrin consumption did not inhibit calcium or magnesium absorption from the gastrointestinal tract in women.

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