Efficacy and Safety of Drotaverine Hydrochloride in Children with Recurrent Abdominal Pain: A Randomized Placebo Controlled Trial.

Walter Bushnell Pvt Ltd0 个研究点目标入组 130 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Children aged between 4 to 12 years of either gender with RAP or non-organic abdominal condition (defined as at least three episodes of pain interfering with normal activities within a three month period).
•2.Children whose parents/legal guardians give written informed consent prior to the study entry.
•3.Children with good health as determined by:
•Medical history
•Physical examination
•Clinical judgment of the investigator

•1.Established organic etiology of abdominal pain (e.g. chronic pancreatitis, cholelithiasis, nephro/urolithiasis, inflammatory bowel disease)
•2.Cognitive-developmental delay or cerebral palsy
•3.Had previous abdominal surgery
•4.Any evidence of acute illness or infection
•5.Children with known immunosuppression/immunodeficiency
•6.Children with history of anaphylaxis, or any serious drug reaction, or allergy to any drug component
•7.Children with any clinical evidence of other chronic diseases such as cardiac, hepatic or renal.

发起方

Walter Bushnell Pvt Ltd