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 pain

Phase 3

Completed

• Conditions: Other abdominal pain, Paroxysmal spastic abdominal pain,

• Registration Number: CTRI/2011/091/000141
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This study is a randomized, open label, active controlled, multicentric study comparing the safety and efficacy of Hyoscine butylbromide 10 mg and Mefenamic acid 250 mg fixed dose combination tablets and Hyoscine butylbromide 10 mg tablets given 4 times daily for the entire study duration in 200 patients with paroxysmal spastic abdominal pain that will be conducted in India. The primary outcome measures will be the change in the pain intensity score during the course of study.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-29
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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 Lactation2.Patients with pain of severe intensity who cannot be managed with oral medications3.Patients with peri-operative pain in the setting of CABG surgery4.Patients with current or history of peptic ulcer, gastrointestinal bleeding or inflammation5.Patients with history of cardiovascular thrombotic events or significant cardiovascular illness6.Patients with high grade fever, myasthenia gravis, megacolon, narrow angle glaucoma and those susceptible to intestinal or urinary outlet obstruction7.Patients with hepatic or renal impairment 8.Hypersensitivity to study medications9.Patients requiring concomitant treatment which is not permissible10.Patients with any other serious concurrent illness or malignancy11.Patients with continuing history of alcohol and / or drug abuse12.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 score	Daily for the entire study period

Secondary Outcome Measures

Name	Time	Method
(1)The degree of improvement in pain relief score	(2)The investigators? global assessment of efficacy

Trial Locations

Locations (5)

Diabetes, Obesity and Thyroid Centre; 🇮🇳 Gwalior, MADHYA PRADESH, India

K2 Clinic, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Medilink Hospital & Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

S.P. Medical College and A.G. Hospitals, Bikaner; 🇮🇳 Bikaner, RAJASTHAN, India

Shashwat Hospital & Research Centre, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Diabetes, Obesity and Thyroid Centre

🇮🇳Gwalior, MADHYA PRADESH, India

Dr Navneet Agrawal

Principal investigator

navneetdotc@gmail.com