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Clinical Trials/CTRI/2011/091/000141
CTRI/2011/091/000141
Completed
Phase 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

Cadila Healthcare Ltd0 sites200 target enrollmentStarted: TBDLast updated:
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ConditionsHealth Condition 1: R108- Other abdominal painHealth Condition 2: null- Paroxysmal spastic abdominal pain

Overview

Phase
Phase 3
Status
Completed
Enrollment
200
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

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

Investigators

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