| CTRI Number |
CTRI/2009/091/000640 [Registered on: 25/09/2009] |
| 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, Faropenem extended release tablets and Faropenem conventional tablets in patients with respiratory tract infections (RTI) |
Scientific Title of Study
Modification(s)
|
A comparative multicentric study to assess the efficacy and safety of Faropenem sodium extended release (ER) tablets in comparison to Faropenem sodium conventional tablets in patients suffering from respiratory tract infections (RTI) |
| Trial Acronym |
extended release (ER).
respiratory tract infections (RTI) |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 08-08 |
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
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862363 |
| 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
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862363 |
| 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
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862363 |
| Email |
r.mittal@zyduscadila.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Cadila Healthcare Ltd. Ahmedabad |
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Ltd |
| Address |
Satellite Cross Roads
Sarkhej Gandhinagar Highway
Ahmedabad 380015
Gujarat INDIA. |
| 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 = 5 |
| 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. Narendra Khippal |
Chest & TB Hospital, Jaipur |
Banglow No. 2, Subhash Nagar Shopping Centre ,Opposite Krishna Kripa- 2-
Jaipur
RAJASTHAN |
drnkhippal@rediffmail.com |
| Dr Mahendra Parmar |
Department of Medicine, Government Medical College, Vadodara |
Associate Professor
Dept of Medicine
Government Medical College
Vadodara
Vadodara
GUJARAT |
9824326550
mcparmar1961@yahoo.co.in |
| 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 |
| Dr. Praveen Garg |
Shashwat Hospital & Research Centre, Ahmedabad |
Consultant Physician, Shashwat Hospital & Research Centre,,323, Satyam Mall, Opposite Vishweshwar Mahadev Temple, Mansi Cross Road, Vastrapur, -
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 of Bansal Hospital and research centre, Jaipur |
Approved |
| Independent Ethics Committee - Aditya (DrMCParmar) |
Approved |
| Independent Ethics Committee - Aditya (DrPravinGarg) |
Approved |
| Independent Ethics Committee - Aditya (DrTusharPatel) |
Approved |
| Institutional Ethical and Research Committee - Mahatma Gandhi Medical College & Hospital (DrPuneetRijhwan) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, (2) ICD-10 Condition: J189||Pneumonia, unspecified organism, Respiratory tract infections (RTI), (3) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Faropenem sodium 200 mg conventional tablets |
one tablet thrice in a day for at least 7 days and for a maximum of 14 days |
| Intervention |
Faropenem sodium 300 mg extended-release tablets |
one tablet twice in a day for at least 7 days and for a maximum of 14 days |
|
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 established infection of the upper or lower respiratory tract (e.g. acute bacterial exacerbation of chronic bronchitis, acute sinusitis and/or community acquired pneumonia)
3. Informed consent of the patient/relative. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy/Lactation/Less than 18 years of age.
2. Grossly abnormal liver or kidney function tests or significant hematological abnormalities.
3. History of known hypersensitivity to any of the penems, penicillincs, cephalosporins or other beta-lactams.
4. Patients with CNS disorders or epilepsy or history of other factors that can predispose to seizures.
5. Patients with serious infections requiring hospitalization or life-threatening in nature where monotherapy with Faropenem sodium would be considered inadequate.
6. Patients receiving any other antibiotic/antibacterial agent in the previous 2/3 days prior to enrolment in the study.
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 clinical success rate in each of the infections as judged by either complete cure at the end of the treatment phase or significant improvement with no need for further antibiotic therapy at the end of the treatment phase. |
7 days & 14 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1) The bacterial eradication rates observed in these patients at the end of therapy
2) Overall assessment of efficacy given to the study medication by the investigator at the end of the study
|
7 days & 14 days |
|
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)
|
13/06/2009 |
| 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="5"
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 Faropenem sodium 300 mg extended-release tablets and Faropenem sodium 200 mg conventional tablets for a maximum of 14 days depending upon the site and severity of the infection in 200 patients with respiratory tract infections (RTI) that will be conducted in five centers in India. The primary outcome measures will be the clinical success rate in each of the infections as judged by either complete cure at the end of the treatment phase or significant improvement with no need for further antibiotic therapy at the end of the treatment phase.
The date of first enrollment in the trial was 13/06/2009. |