A clinical trial to study effectiveness and safety of Fixed dose combination tablets of Hyoscine butylbromide & Mefenamic acid in patients suffering from paroxysmal spastic abdominal pai
- Conditions
- Health Condition 1: R108- Other abdominal painHealth Condition 2: null- Paroxysmal spastic abdominal pain
- Registration Number
- CTRI/2011/091/000141
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The degree of improvement in the pain intensity scoreTimepoint: Daily for the entire study period
- Secondary Outcome Measures
Name Time Method (1)The degree of improvement in pain relief score <br/ ><br>(2)The investigators? global assessment of efficacyTimepoint: Daily and at the end of study