CTRI/2011/091/000141CompletedPhase 3
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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Cadila Healthcare Ltd
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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