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临床试验/CTRI/2011/091/000141
CTRI/2011/091/000141已完成3 期

A randomized, open label, comparative, multicentric, phase 3 clinical study to assess the efficacy and safety of Fixed dose combination tablets of Hyoscine butylbromide & Mefenamic acid in comparison with Hyoscine butylbromide tablets in patients suffering from paroxysmal spastic abdominal pain - None

Cadila Healthcare Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Patients of either sex of 18 to 60 years of age
  • 2.Patients with clinical diagnosis of paroxysmal spastic abdominal pain
  • 3.Informed consent

排除标准

  • 1.Pregnancy and/or Lactation
  • 2.Patients with pain of severe intensity who cannot be managed with oral medications
  • 3.Patients with peri-operative pain in the setting of CABG surgery
  • 4.Patients with current or history of peptic ulcer, gastrointestinal bleeding or inflammation
  • 5.Patients with history of cardiovascular thrombotic events or significant cardiovascular illness
  • 6.Patients with high grade fever, myasthenia gravis, megacolon, narrow angle glaucoma and those susceptible to intestinal or urinary outlet obstruction
  • 7.Patients with hepatic or renal impairment
  • 8.Hypersensitivity to study medications
  • 9.Patients requiring concomitant treatment which is not permissible
  • 10.Patients with any other serious concurrent illness or malignancy
  • 11.Patients with continuing history of alcohol and / or drug abuse
  • 12.Participation in another clinical trial in the past 3 months

研究者

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