Health Condition 1: R108- Other abdominal pain Health Condition 2: null- Paroxysmal spastic abdominal pain
Conditions
Interventions
Intervention1: Hyoscine butylbromide 10 mg &
Mefenamic acid 250 mg fixed dose combination tablet: One tablet four times daily for entire study duration
Control Intervention1: Hyoscine butylbromide 10 mg tablet: One tablet four times daily for en
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of improvement in the pain intensity scoreTimepoint: Daily for the entire study period | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The degree of improvement in pain relief score (2) The investigators? global assessment of efficacyTimepoint: Daily and at the end of study | — |
Countries
India
Contacts
Public ContactDr Amit Kubavat
Cadila Healthcare Ltd.
Outcome results
None listed