| CTRI Number |
CTRI/2009/091/000639 [Registered on: 08/12/2009] |
| Last Modified On: |
13/11/2018 |
| 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 the effects of two drugs, Zileuton extended-release tablets and Montelukast sodium 10 mg tablets in patients with bronchial asthma. |
Scientific Title of Study
Modification(s)
|
An open label, comparative, multicentric study to assess the efficacy and safety of Zileuton extended-release tablets in comparison with Montelukast sodium tablets in patients suffering from bronchial asthma |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 08-05 |
Protocol Number |
|
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, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head-Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head-Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
R.Mittal@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 Road,
Opp. ISCON Temple, S-G-Highway
Ahmedabad – 380 015
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Tushar B. Patel |
ASHRAI ASSOCIATES, Ahmedabad |
Consultant Pulmonologist & Critical Care Specialist ,ASHRAI ASSOCIATES, 110, 111,112 Ellisbridge centre, Ellisbridge-
Ahmadabad
GUJARAT |
079-26579550
drtusharpatel@yahoo.com |
| Dr Nalin Shah |
B.J. Medical College & Civil Hospital, Ahmedabad |
Dept. of T. B. & Chest Diseases,B.J. Medical College & Civil Hospital, Ahmedabad-380016
Ahmadabad
GUJARAT |
079-22683721
nalintshah@yahoo.co.in |
| Dr Narendra Khippal |
Chest & TB Hospital, Jaipur |
Chest & TB Hospital,,Banglow No. 2, Subhash Nagar Shopping Centre,-
Jaipur
RAJASTHAN |
9829017619
drnkhippal@rediffmail.com |
| Dr Sandeep Tak |
Dr. S. N. Medical College, Jodhpur |
Assistant Professor Dept. of General Medicine ,Dr. S. N. Medical College
Jodhpur
RAJASTHAN |
9828069159
drstak@yahoo.com |
| Dr. Salil Bhargava |
Gyan Pushp Research Centre for Chest & Allergy Disease, Indore. |
Consultant Pulmonologist, Gyan Pushp Research Centre for Chest & Allergy Disease,,Major Jagdale Marg, South Tukoganj, Indore-452001
Indore
MADHYA PRADESH |
+91731 2711271, 2529173
bhargavasalil@hotmail.com |
| Dr. Puneet Rijhwani |
Mahatma Gandhi National Institute of Medical Sciences, Jaipur |
Associate Professor, Department Of Medicine,,Mahatma Gandhi National Institute Of Medical Sciences-
Jaipur
RAJASTHAN |
+91-141-2771777 Ext# 258, 2771001-2-3
puneet284@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bansal Hospital and Research centre |
Approved |
| Ethics Committee- Diabetes Thyroid Hormone Research Institute Pvt. Ltd., Indore |
Approved |
| Independent Ethics Committee - Aditya |
Approved |
| Institutional Ethical and Research Committee - Mahatma Gandhi Medical College & Hospital |
Approved |
| Institutional Ethical Committee - Dr. S. N. Medical College & Associated Group of Hospitals, Jodhpur |
Approved |
| Institutional Ethics Committee - B. J. Medical College & Civil Hospital, Ahmedabad |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Bronchial asthma, (1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Montelukast sodium 10 mg tablets |
one tablet daily in the evening with or without food for 12 weeks |
| Intervention |
Zileuton 600 mg extended-release tablets |
two tablets twice in a day within 1 hour after morning and evening meals for 12 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between 18-65 years of age
2. Patients with an established diagnosis of mild to moderate chronic persistent bronchial asthma
3. Informed consent of the patient/relative
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy and/or lactation
2. Patients with severe or unstable bronchial asthma or having acute asthmatic attack at the time of enrolment
3. Patients with a clinically relevant respiratory tract infection in the four weeks prior to enrolment
4. Patients with liver dysfunction i.e., active liver disease or persistent hepatic function enzyme elevations ≥3 times the upper limit of normal
5. Patients with any other clinically significant illness
6. Patients with a history of hypersensitivity to any of the components of the study medications
7. Patients with any other serious concurrent illness or malignancy
8. Patients with continuing history of alcohol and / or drug abuse
9. 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 mean PEFR at each visit and at the end of the study as compared to baseline |
4,8 & 12 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The degree of improvement in the overall symptoms (cough, wheeze, chest tightness, and shortness of breath) as assessed on a 4-point scale as mentioned above at each visit and at the end of the study as compared to baseline |
4,8 & 12 weeks |
|
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)
|
06/06/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
“none yet†|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is an open label, comparative, multicentric study comparing the safety and efficacy of Zileuton 600 mg extended-release tablets and Montelukast sodium 10 mg tablets for 12 weeks in 200 patients with bronchial asthma that will be conducted in four centers in India. The primary outcome measures will be the degree of improvement in mean PEFR at each visit and at the end of the study as compared to baseline. The date of enrollment of first patient is 06/06/2009 and 200 patients are proposed to be enrolled in this trial to be conducted only in India. |