| CTRI Number |
CTRI/2010/091/001368 [Registered on: 15/09/2010] |
| Last Modified On: |
14/11/2018 |
| 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 effectiveness and safety of Acrivastine capsules in comparison with Chlorpheniramine maleate tablets in patients suffering from allergic rhinitis |
Scientific Title of Study
Modification(s)
|
A randomized, open label, comparative, multicentric study to assess the efficacy and safety of Acrivastine capsules in comparison with Chlorpheniramine maleate tablets in patients suffering from allergic rhinitis |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 09-13 |
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 |
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 |
Cadila Healthcare Ltd. |
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads
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
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 |
Zydus Tower, Satellite Cross Road, 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 Sonia Dalal |
Ashray Chest Centre, Vadodara |
Ashray Chest Centre,101-102, Shree Hari Complex, Behind Express Hotel, Alkapuri-390007
Vadodara
GUJARAT |
02652340012
drsoniadalal@hotmail.com |
| Dr S Z Jafrey |
Dr. Jafreys Indore Chest Centre, Indore |
Dr. Jafreys Indore Chest Centre,1st floor, Morya Arcade, Old Palasia, Opposite Palasia Thana -452018
Indore
MADHYA PRADESH |
07312566788
indorechestcentre@yahoo.com |
| Dr Narendra Khippal |
Dr. Khippals Clinic, Jaipur |
Dr. Khippals Clinic,B. No. 2, Subhash Shopping Centre-302016
Jaipur
RAJASTHAN |
9829017619
drnkhippal@rediffmail.com |
| Dr Tarun Ojha |
Dr. Tarun Ojhas ENT Centre, Jaipur |
Dr. Tarun Ojhas ENT Centre,Manav Ashram, Near Gopalpura Flyover, Tonk Road-302215
Jaipur
RAJASTHAN |
09314140711
drtarunojha_ent@yahoo.com |
| Dr Praveen Garg |
Shashwat Hospital & Research Centre, Ahmedabad |
Shashwat Hospital & Research Centre,323 ? Satyam Mall, Opp. Vishveshvaray Mahadev Mandir, Jodhpur 4 rasta -380015
Ahmadabad
GUJARAT |
07926741500
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 & Research Centre, Jaipur |
Approved |
| Independent Ethics Committee - Aditya (DrPraveenGarg) |
Approved |
| Independent Ethics Committee - Aditya (DrSoniaDalal) |
Approved |
| Independent Ethics Committee - Aditya (DrSZJafrey) |
Approved |
| Independent Ethics Committee - Aditya (DrTarunOjha) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Allergic rhinitis, (1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Acrivastine 8 mg capsules |
One capsule thrice daily for 2 weeks |
| Comparator Agent |
Chlorpheniramine maleate 4 mg tablets |
One tablet thrice daily for 2 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex of 18 to 65 years of age
2. Established diagnosis of allergic rhinitis
3. Informed consent
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy & Lactation.
2. Significant renal impairment.
3. Narrow-angle glaucoma, GI or GUT obstruction.
4. Patients with acute attack of bronchial asthma or those on corticosteroids.
5. Nasal structural abnormalities
6. Upper respiratory tract infection
7. Hypersensitivity to study medications
8. Patients with any other serious concurrent illness or malignancy
9. Continuing history of alcohol and / or drug abuse
10. Recent participation in another clinical trial
|
|
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 change in the total symptom score |
0,1,2 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The change in the total and individual nasal and ocular symptom scores |
0,1,2 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)
|
15/09/2010 |
| 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 Acrivastine 8 mg capsules and Chlorpheniramine maleate 4 mg tablets given thrice daily each for 2 weeks; in 200 patients with allergic rhinitis that will be conducted in India. The primary outcome measures will be the change in total symptom score of nasal and ocular symptoms during the course of study. |