| CTRI Number |
CTRI/2011/091/000141 [Registered on: 01/02/2011] |
| Last Modified On: |
14/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
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 |
Scientific Title of Study
Modification(s)
|
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 |
| Trial Acronym |
None |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| None |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads, Ahmadabad - 380015.
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868211 |
| Fax |
079-26862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Amit Kubavat |
| Designation |
Sr. Manager - Clinical & Regulatory Affairs |
| Affiliation |
Cadila Healthcare Ltd. |
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads, Ahmadabad - 380015.
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868812 |
| Fax |
079-26862362 |
| Email |
amitkubavat@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Amit Kubavat |
| Designation |
Sr. Manager - Clinical & Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads, Ahmadabad - 380015.
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868812 |
| Fax |
079-26862362 |
| Email |
amitkubavat@zyduscadila.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd., Zydus Tower, Satellite Cross Roads, Ahmedabad - 380015, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| None |
Not Applicable |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Navneet Agrawal |
Diabetes, Obesity and Thyroid Centre |
Diabetes, Obesity and Thyroid Centre, 19 - Hospital road, Lalitpur colony, Gwalior - 474001.
Gwalior
MADHYA PRADESH |
0751-3206777
navneetdotc@gmail.com |
| Dr. Puneet Rijhwani |
K2 Clinic, Jaipur |
14/201, Malviya Nagar,-302017
Jaipur
RAJASTHAN |
puneet284@rediffmail.com |
| Dr Manish Agrawal |
Medilink Hospital & Research Centre |
Medilink Hospital & Research Centre, Nr. Shyamal Char Rasta, Satellite, Ahmedabad - 380015.
Ahmadabad
GUJARAT |
079-26762821
medilinkresearchcentre@yahoo.com |
| Dr V B Singh |
S.P. Medical College and A.G. Hospitals, Bikaner |
Department of Medicine, S.P. Medical College and A.G. Hospitals, Bikaner-334003.
Bikaner
RAJASTHAN |
0151-2226300
vbsingh2@rediffmail.com |
| Dr. Praveen Garg |
Shashwat Hospital & Research Centre, Ahmedabad |
323 ? Satyam Mall,,Opp. Kameshwar School, Jodhpur cross roads-380015
Ahmadabad
GUJARAT |
praveen_k_garg@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee - S.P. Medical College and A.G. Hospitals, Bikaner |
Approved |
| IEC - Aditya for Dr. Navneet Agrawal |
Approved |
| IEC - Aditya for Dr. Praveen Garg |
Approved |
| IEC - Aditya for Dr. Puneet Rijhwani |
Approved |
| Medilink Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R108||Other abdominal pain, Paroxysmal spastic abdominal pain, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Hyoscine butylbromide 10 mg & Mefenamic acid 250 mg fixed dose combination tablet |
One tablet four times daily for entire study duration |
| Comparator Agent |
Hyoscine butylbromide 10 mg tablet |
One tablet four times daily for entire study duration |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The degree of improvement in the pain intensity score |
Daily for the entire study period |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
(1) The degree of improvement in pain relief score
(2) The investigators? global assessment of efficacy |
Daily and at the end of study |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
29/01/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
29/01/2011 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. |