A Prospective, Single Arm, Open Label, Multicentric Study to Determine the Safety and Effectiveness of AnafortanÂ® Syrup (Camylofin Dihydrochloride 12.5 mg plus Paracetamol IP 125 mg)/ 5 ml in Children with Acute Colicky Abdominal Pain in India - AHPLIN1702

Abbott Healthcare Limited0 个研究点目标入组 197 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Children of either gender aged 8 to12 years
•2.Children presenting with acute colicky abdominal pain and having history of at least one episode of acute colicky abdominal pain in the 24-hour period prior to screening
•3.Children willing to provide assent and parents/ legal guardian /legally acceptable representative (LAR) willing to give written informed consent for participation of their children

•1.Children with history of taking AnafortanÂ® syrup or any other prescription analgesics and antispasmodics medication (within the previous 1 week before study enrollment).
•2.Parents/legal guardian/LAR unwilling or unable to comply with the study procedures and/or make daily diary entries for their children
•3.History of hypersensitivity/ allergy to study drug and its constituents
•4.Any other illness or conditions that does not justify patientâ??s participation in the study as judged by the investigator

发起方

Abbott Healthcare Limited