Prospan® Hustenzäpfchen – Investigation on efficacy and tolerability in children: A double-blind, placebo controlled, randomised, multi-centre, comparative study with parallel groups for the symptomatic treatment of acute bronchitis accompanied by coughing in children - Prospan® Hustenzäpfchen – Investigation on efficacy and tolerability in children

Engelhard Arzneimittel GmbH & Co. KG0 个研究点开始时间: 2008年3月17日最近更新: 2012年5月8日

适应症

试验速览

暂无简介。

•1. male or female children aged 0 to 6 years
•2. acute bronchitis existing not longer than three days and accompanied by coughing
•3. symptom rating score of = 5 assessed by the investigator
•4. symptom ‘frequency of coughing’ of = 2 assessed by the investigator
•5. the patient’s legal representatives must give informed consent in accordance with the supposed will of the patient, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the risk for patients participating in the study
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. hypersensitivity to the active ingredient or to any further constituents of the pharmaceutical preparations
•2. patients with severe allergies or multiple drug allergies
•3. any other pulmonary disease within the last two weeks
•4. chronic pulmonary diseases
•5. exacerbation of chronic pulmonary disease
•6. suspicion of bacterial pulmonary infection
•7. fever above 39 °C (rectal measurement)
•8. participation in a clinical trial during the last two months prior to the individual enrolment of the patient
•9. any systemic treatment with antibiotics or any systemic treatment with immunosuppressives within 2 weeks prior to the first administration
•10. impossibility to rectally apply suppositories (e.g. due to rectal injuries, rectal bleeding, anal fissures or fistulas, haemorrhoids, perianal inflammation caused by bacterial or fungal infection, bowel diseases)
•11. any hints for presence of haemolysis
•12. patients or their legal representatives suspected or known not to follow instructions or not to correctly complete a diary
•13. patients or their legal representatives who are unable to understand the written and/or verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study

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