| CTRI Number |
CTRI/2017/09/009643 [Registered on: 05/09/2017] Trial Registered Prospectively |
| Last Modified On: |
17/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
An Observational Post Marketing study to check the safety and tolerance of Alerfix Total in patients with Asthma |
|
Scientific Title of Study
|
A Phase IV , Randomized, Open Label, multicentre study to confirm the safety and tolerability of Alerfix Total (Levocetirizine, Montelukast, Ambroxol) in patients with Non specific respiratory symptoms (NSRS) with Asthma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajaykumar B Malle |
| Designation |
General Manager Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt Ltd |
| Address |
Clinical Development Services
A77, Khairne MIDC, TTC Industrial Area, Khairne, Navi Mumbai
Mumbai
MAHARASHTRA
400709
India |
| Phone |
02227780718 |
| Fax |
02227780720 |
| Email |
ajay.malle@accutestglobal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajaykumar B Malle |
| Designation |
General Manager Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt Ltd |
| Address |
Clinical Development Services
A77, Khairne MIDC, TTC Industrial Area, Khairne, Navi Mumbai
Mumbai
MAHARASHTRA
400709
India |
| Phone |
02227780718 |
| Fax |
02227780720 |
| Email |
ajay.malle@accutestglobal.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hiren Gandhecha |
| Designation |
Manager - Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt Ltd |
| Address |
Clinical Development Services
Opp. The Grand Bhagwati,
S.G. Highway,
Bodakdev
Ahmadabad
GUJARAT
380 059
India |
| Phone |
07940231600 |
| Fax |
07940029317 |
| Email |
hiren.gandhecha@accutestglobal.com |
|
|
Source of Monetary or Material Support
|
| Eris Life sciences Pvt Ltd, 7th Floor, Commerce House IV, Besides Shell Petrol Pump, 100 Feet Road, Prahladnagar, Ahmedabad – 380015 Gujarat,India. |
|
|
Primary Sponsor
|
| Name |
Eris Life sciences Pvt Ltd |
| Address |
7th Floor, Commerce House IV, Besides Shell Petrol Pump, 100 Feet Road, Prahladnagar, Ahmedabad – 380015 Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Kamlesh Fatania |
Devi Hospital |
Devi Hospital, 1st Floor Sagar complex, opp Mansi Tower, Premchandranagar Road, Vastrapur 380015
Ahmadabad
GUJARAT |
09825466788
drkamlesh_fatania@yahoo.co.in |
| Dr Jitendra Anand |
Kanoria Hospital & Research Centre |
Kanoria Hospital & Research Centre, Near Indira bridge, Hansol Gandhinagaer Highway, Bhat, Gandhinagar, Ahmedabad Gujarat 382428
Ahmadabad
GUJARAT |
09824517101
jkanand09@gmail.com |
| Dr Ronak Shah |
Poojan Multispeciality Hospital |
Poojan Multispeciality Hospital, First Floor, Navnidhi Avenue, Gurukul Road, Subhash Chowk, Memnagar, Ahmedabad 380052
Ahmadabad
GUJARAT |
09898783040
poojan.research@gmail.com |
| Dr Nirmal Parmar |
Prisha Medical Care |
Prisha Medical Care, 19, 2nd Floor, Nakshatra Avenue, Opp. Manikrupa School, IOC Road, Chandkheda, Ahmedabad 382424
Ahmadabad
GUJARAT |
09924493190
dr_nirmal82@yahoo.com |
| Dr Gaurav Chhaya |
Sanjivani Super Speciality Hospitals Pvt. Ltd. |
Sanjivani Super Speciality Hospitals Pvt. Ltd.
1, Uday Park Society, Nr. Sunrise Park,
Vastrapur, Ahmedabad - 380015.
Ahmadabad
GUJARAT |
09825324056
gaurav.chhaya2010@yahoo.com |
| Dr Chetna Nayak |
Shri Umiya Multispeciality Hospital |
Shri Umiya Multispeciality Hospital, Raj Bunglows, Ramji Temple Road, Ranip, Ahmedabad - 382480
Ahmadabad
GUJARAT |
09825841059
ndrchetan@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Kanoria Ethics Committee |
Submittted/Under Review |
| Sangini Hospital Ethics Committee ( Poojan Multispeciality Hospital-Dr Ronak Shah) |
Approved |
| Sangini Hospital Ethics Committee ( Shri Umiya Multispeciality Hospital-Dr Chetan Nayak) |
Approved |
| Sangini Hospital Ethics Committee (Devi Hospital-Dr Kamlesh Fatania) |
Approved |
| Sangini Hospital Ethics Committee (Prisha Medical Care-Dr Nirmal Parmar) |
Approved |
| Sanjivani Hospital Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, Patients with Cough and/or wheeze and/or chronic dyspnoea with asthma., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Tablet Alerfix Total |
Montelukast 10 MG+Levocetirizine 5 MG+Ambroxol 75 MG |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Men or Women, between 18 to 80 years of age (both inclusive).
2. The patient experiencing Cough and/or wheeze and/or chronic dyspnoea or any other symptoms of NSRS with asthma
3. Patient indication and disease condition according to the “INDICATION & USAGE†as mentioned in the package insert available with Alerfix Total
4. Women of childbearing potential using an acceptable method of birth control.
5. Willing to give written informed consent for participation in the study and to comply with the study procedures
|
|
| ExclusionCriteria |
| Details |
1. Evidence of active liver disease or SGPT > 2.5 times upper limit of normal (ULN)
2. Evidence of renal impairment (Serum creatinine levels more than 2.0 mg /dl)
3. Pregnancy
4. Malignancy
5. Contraindication as mentioned in package insert
6. Patients with medical conditions that preclude the follow-up as defined in the protocol or otherwise limits participation in this study
7. Patients with known history of hypersensitivity to the study drug |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore the overall safety profile of Alerfix total, as measured by adverse events and Questionnaires, in patients with NSRS and asthma under conditions of routine medical practice. |
Not Applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/09/2017 |
| 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
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is Randomized, Open Label and multicentre study, designed to evaluate the efficacy and safety of study drug Alerfix Total. This study will include patients with NSRS with asthma by their treating physician in accordance with the respective local prescribing information and routine clinical practice The patients treated with Alerfix Total will be followed for assessment of safety parameters throughout the study (2 weeks). Visual analog scale scores will be assessed at baseline (Day 1 before the treatment), day 7 and at end of the treatment (day 14).Quality of life will be assessed at baseline (Day 1 before the treatment), day 7 and at end of the treatment (day 14). Adverse events will be recorded throughout the study.
|