| CTRI Number |
CTRI/2009/091/001041 [Registered on: 15/02/2010] |
| Last Modified On: |
28/03/2013 |
| 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
|
CLINICAL TRIAL TO COMPARE EFFICACY AND SAFETY OF FIXED DOSE COMBINATION OF DOXOPHYLLINE 800 mg SR AND MONTELUKAST 10 mg WITH DOXOPHYLLINE 800mg SR IN SUBJECTS SUFFERING WITH ACUTE BRONCHOSPASM |
|
Scientific Title of Study
|
?A CONTROLED LABELED, DOUBLE ARM, RANDOMIZED, MULTI- CENTRIC, PROSPECTIVE PHASE III CLINICAL TRIAL TO COMPARE EFFICACY AND SAFETY OF FIXED DOSE COMBINATION OF DOXOPHYLLINE 800 mg SR AND MONTELUKAST 10 mg WITH DOXOPHYLLINE 800mg SR IN SUBJECTS SUFFERING WITH ACUTE BRONCHOSPASM OF DIFFERENT ETIOLOGY? |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEX/SG-501/24/12/2008 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Bhambe |
| Designation |
|
| Affiliation |
|
| Address |
NARENDER PRAKASH HEALTH CARE CENTRE
DA-3/A ,MAIN VIKAS MARG ,SHAKAR PUR,OPP.NATHU SWEETS ,BEHIND POLICE BOOTH
New Delhi
DELHI
110092
India |
| Phone |
09212052184 |
| Fax |
nil |
| Email |
dbhambe@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sameena khan |
| Designation |
|
| Affiliation |
CRA |
| Address |
NEXUS CRO Anuj?, Plot No. 45, Ist Floor,
Mumbai-Pune Highway, Near D. Y. Patil Stadium,Sector-13, Nerul (E),
Mumbai
MAHARASHTRA
400 706
India |
| Phone |
09891783557 |
| Fax |
NIL |
| Email |
sameena.k@nexuscro.com |
|
Details of Contact Person
Public Query
|
| Name |
mr shunmugam |
| Designation |
|
| Affiliation |
|
| Address |
Swiss Garnier Life SciencesNo. 68A,
Vembuli Amman koli St, Alandur,
Chennai
TAMIL NADU
600016
India |
| Phone |
044-22329837,22312892 |
| Fax |
NIL |
| Email |
qc@swissgarnier.com |
|
|
Source of Monetary or Material Support
|
| nexus clinical research organization,
annuj plot -45,sector 13,nerul new mumbai |
|
|
Primary Sponsor
|
| Name |
Swiss Garnier Life SciencesNo. 68A, Vembuli Amman koli St, Alandur, Chennai 600016 .Phone : 044-22329837, 22312892 |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanu Raj Sirohi |
3, Nandan Kunj, W K Road |
3, Nandan Kunj, W K Road,nil-250001
Meerut
UTTAR PRADESH |
9917000583
NIL
trsirohi@yahoo.com |
| Dr Saurbh Singh |
C-29/ 24 Dilshad Gardens, |
C-29/ 24 Dilshad Gardens, ,DELHI-110095
New Delhi
DELHI |
09899495290
NIL
docsaurabh76@rediffmail.com |
| Dr Satish Kumar Gupta |
E-84 Lajpat Nagar |
E-84 Lajpat Nagar,NIL-110024
New Delhi
DELHI |
9811212494
NIL
Kumar6511@gmail.com |
| Dr. Deepak Bhambe |
Flat No 11, Ashirwad Apt. IP Extension |
Flat No 11, Ashirwad Apt. IP Extension,NIL-110092
New Delhi
DELHI |
9212052184
NIL
bhambe@yahoo.com |
| Dr. Harsh Sharma |
Govt medical college & hospital |
Govt medical college & hospital,jammu-190001
Jammu
JAMMU & KASHMIR |
9419114218
NIL
harshbadyal@yahoo.in |
| DR K MOHAN PAI |
Mangalore heart center |
Mangalore heart center,No.8 ?city point? Kodialbail-575003
Bangalore
KARNATAKA |
9845083135
nil
mohanpai@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTE CLINICAL RESEARCH (INDIA),PLOT NO 90,POCKET -A,SECTOR -17,DAWARKA -NEW DELHI(FOR DR TANURAJ SAROHI)) |
Approved |
| THE CENTRAL INDEPENDENT ETHICS COMMITTE CLINICAL RESEARCH (INDIA),PLOT NO 90,POCKET -A,SECTOR -17,DAWARKA -NEW DELHI(FOR DR DEEPAK BHAMBE) |
Approved |
| THE CENTRAL INDEPENDENT ETHICS COMMITTE CLINICAL RESEARCH (INDIA),PLOT NO 90,POCKET -A,SECTOR -17,DAWARKA -NEW DELHI(FOR DR HARSH SHARMA) |
Approved |
| THE CENTRAL INDEPENDENT ETHICS COMMITTE CLINICAL RESEARCH (INDIA),PLOT NO 90,POCKET -A,SECTOR -17,DAWARKA -NEW DELHI(FOR DR K M PAI) |
Approved |
| THE CENTRAL INDEPENDENT ETHICS COMMITTE CLINICAL RESEARCH (INDIA),PLOT NO 90,POCKET -A,SECTOR -17,DAWARKA -NEW DELHI(FOR DR SATISH GUPTA) |
Approved |
| THE CENTRAL INDEPENDENT ETHICS COMMITTE CLINICAL RESEARCH (INDIA),PLOT NO 90,POCKET -A,SECTOR -17,DAWARKA -NEW DELHI(FOR DR SAURABH SINGH) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
patient suffering with Acute BRONCHOSPASM OF DIFFERENT ETIOLOGY, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DOXOPHYLLINIntervention: IMP FDC OF DOXOFYLLINE 800mg SR AND MONTELUKAST 10mg |
800MG,100MG(10 DAYS) |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex of age ≥ 18 and ≤ 70 years.
Patient suffering from mild to moderate bronchospasm of different etiology.
PEF between 50% to 80 % (mild to moderate)by using Peak flow meter.
Pre menopausal women must use the appropriate contraception.
Patient willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients with significant pulmonary insufficiency, including both intrinsic lung disease and Respiratory failure i.e. severe bronchospasm
Patient with a history of known hypersensitivity from any one of the said medication.
Patients with acute myocardial infarction, hypotension.
Patients with uncontrolled hypertension.
Bronchospasm of anaphylactic, mechanical or cancerous origin.
Subjects with severe hepatic, renal failure or encephalopathy.
Chronic alcoholics.
Patients with history of cardiac surgery.
Pregnant & lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of the FDC of Doxophylline 800 mg SR and Montelukast 10 mg against Doxophylline 800 mg SR in subjects suffering with acute bronchospasm of different etiology. |
10 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the safety & tolerability of FDC of Doxophylline 800 mg SR and
Montelukast 10 mg against Doxophylline 800 mg SR on oral administration in subjects suffering with acute bronchospasm of different etiology
|
10 DAYS |
|
Target Sample Size
Modification(s)
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
18/09/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be conducted after obtaining written informed consent from subjects. Subjects will go through medical screening during pre-enrollment visit (Visit 1). Screening will include complete clinical evaluation (Demographic data, physical examination, clinical symptoms). All demographic data and other symptoms will be recorded in the case report form. Routine haematological examinations like Hb, TLC, DLC, hepatic functions (SGOT, SGPT), renal functions (serum Creatinine, serum uric acid) and baseline PEF by using Peak Flow meter will be done on screening. Urine pregnancy test will be done in female subjects of the age of child bearing capability at the start of the therapy. Subjects who met the eligibility criteria will be enrolled into the study. On visit 2 first dose of drug will be administered & remaining doses will subject diary for self assessment of quality of life by using ADL Scale. Follow up will be done for subsequent visits (Day 4, Day 7 and Day 10) with efficacy evaluation (PEF by using Peak Flow meter) and safety & tolerability parameters will be evaluated. On completion of therapy all lab parameters will be repeated again.
However, patients will be allowed to visit the investigator at time points other than specified in the protocol in case of any adverse event or depending upon the discretion of the investigator.
|