| CTRI Number |
CTRI/2010/091/000589 [Registered on: 12/07/2010] |
| Last Modified On: |
02/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, cefopodoxime and dicloxacillin in patients with various bacterial respiratory tract infections. |
|
Scientific Title of Study
|
?A control labeled, double arm, comparative, multicentric, prospective, Phase III trial to compare the safety and efficacy of fixed dose combination of Cefpodoxime 200mg and Dicloxacillin 500mg with Cefpodoxime 200mg in subjects suffering with various bacterial respiratory tract infections.? |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEX/TP-031/29/12/08 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Nitin M Rathod |
| Designation |
|
| Affiliation |
|
| Address |
R N Cooper Hospital, Mumbai
Mumbai
MAHARASHTRA
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nitin M Rathod |
| Designation |
|
| Affiliation |
|
| Address |
R N Cooper Hospital, Mumbai
Mumbai
MAHARASHTRA
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nitin M Rathod |
| Designation |
|
| Affiliation |
|
| Address |
R N Cooper Hospital, Mumbai
Mumbai
MAHARASHTRA
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
|
Source of Monetary or Material Support
|
| M/s. Theon Pharmaceutical Ltd. |
|
Primary Sponsor
Modification(s)
|
| Name |
Ms Theon Pharmaceuticals Ltd |
| Address |
Village - Saini majra, Nalagarh, Dist- Solan (H.P.), India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rajiv R Oza |
Clinic, Bhavnagar, Rajivoza59@hotmail.com |
,-
Bhavnagar
GUJARAT |
Rajivoza59@hotmail.com |
| Dr. Nitin Rathod |
Dr. R N Cooper Hospital,Mumbai, nitinmr@yahoo.in |
,-400057
Mumbai
MAHARASHTRA |
|
| Dr. Sudhakar Vyavahare |
Dr. Sudhakar Vyavahare?s Clinic, Nashik, sudhakar.vyavahare@yahoo.com |
,-
Nashik
MAHARASHTRA |
sudhakar.vyavahare@yahoo.com |
| Dr. kirtilata Gillurkar |
Gillurkar Multispeciality Hospital Pvt. Ltd.,Nagpur, drkirtilata@yahoo.com |
,-
Nagpur
MAHARASHTRA |
drkirtilata@yahoo.com |
| Dr. kirti Patel |
K E M Hospital, Mumbai, pkirtic@yahoo.in |
,-
Mumbai
MAHARASHTRA |
pkirtic@yahoo.in |
| Dr. V.S. Chandarana |
Kusum Medical Nursing Home,Rajkot, drvijaykusum@yahoo.co.in |
,-
Rajkot
GUJARAT |
drvijaykusum@yahoo.co.in |
| Dr. Raj G Bhagat |
N H L Medical college & Hospital, Ahmedabad, Rajpurvi@yahoo.com |
,-
Ahmadabad
GUJARAT |
Rajpurvi@yahoo.com |
| Dr. Rahul Pai |
Pai Clinic Diagnostic Centre,Pune, pairahul73@gmail.com |
,-
Pune
MAHARASHTRA |
pairahul73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTS |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
bacterial respiratory tract infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cefpodoxime 200mg and Dicloxacillin 500mg |
once daily |
| Comparator Agent |
Cefpodoxime 200mg and Dicloxacillin 500mg |
twice daily |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Male and female subjects in the age of 18-70 years shall be selected.
- Subjects suffering from respiratory tract infections.
-Subjects with normal RFT &LFT.
- Subjects willing to give informed consent |
|
| ExclusionCriteria |
| Details |
- Patients with significant primary insufficency including both intrinsic lung disease and respiratory failure.
- Patients with pulmonary tuberculosis.
- Patients with a history of known hypersensitivity from any one of the said medication.
- Patients with acute myocardial infaraction, hypotension.
- patients with uncontrolled hypertension.
_ subjects with severe hepatic, renal failure or encephalopathy.
- Chronic alcoholics.
- Patients with histiry of cardiac surgery.
-Pregnant & lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical and bacteriological/radiological parameters of the FDC of Cefopodoxime and Dicloxacillin in subjects with above mentioned infections. |
5 and 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see the safety and tolerability of FDC by observing the incidence of adverse events as assessed by clinical evaluation and laboratory parameters |
5 to 10 days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/04/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open label, parallel group, multicentre trial comparing the safety and efficacy of Cefopodoxime 200mg and Dicloxacillin 500mg in 200 patients with respiratory infections will be conducted in eight centres in India |