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CTRI Number  CTRI/2010/091/001058 [Registered on: 05/07/2010]
Last Modified On: 01/03/2013
Post Graduate Thesis   
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of Olopatadine Extended Release Tablets, in patients with seasonal allergic rhinitis.  
Scientific Title of Study   Comparative Efficacy, Safety and Tolerability of Olopatadine Extended Release Tablets and Olopatadine Immediate Release Tablets in the Treatment of Seasonal Allergic Rhinitis - A Randomized, Double-Blind Study.  
Secondary IDs if Any  
Secondary ID  Identifier 
ROLOPA103005  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanchan Tyagi  
Designation   
Affiliation   
Address  Project Leader, MACR, Ranbaxy Research Laboratories, Ltd
Plot No.77-B, Sector-18, IFFCO Road
Gurgaon
HARYANA
122015
India 
Phone  +911244194218   
Fax  +911244107000  
Email  kanchan.tyagi@ranbaxy.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr. Shilpa Sharma 
Designation   
Affiliation   
Address  Medical Monitor, MACR, Ranbaxy Research Laboratories, Ltd
Plot No.77-B, Sector-18, IFFCO Road
Gurgaon
HARYANA
122015
India 
Phone  +911244194225  
Fax  +91124410700  
Email  shilpa.sharma@ranbaxy.com   
 
Details of Contact Person
Public Query
 
Name  Kanchan Tyagi  
Designation   
Affiliation   
Address  Project Leader, MACR, Ranbaxy Research Laboratories, Ltd
Plot No.77-B, Sector-18, IFFCO Road
Gurgaon
HARYANA
122015
India 
Phone  +911244194218   
Fax  +911244107000  
Email  kanchan.tyagi@ranbaxy.com   
 
Source of Monetary or Material Support  
Ranbaxy Laboratories Ltd., Plot No. 20, Sector 18, Gurgaon - 122015 , Haryana  
 
Primary Sponsor
Modification(s)  
Name  Ranbaxy Laboratories Ltd  
Address  Plot No. 20, Sector 18, Gurgaon - 122015 , Haryana  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 16  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Akash Lataru Balki   Chest Care Hospital  231, Sakkardara Square, Umred Road, Nagpur-09,-

 
0712-2705904, 09890812215

akash_balki@yahoo.com 
Dr. Ashish S. Chikhale  Chikhale Multispeciality and Cancer Hospital  Dyaneshwar Nagar, Manewada Road, Nagpur,-

 
0712-2740030, 09822217345

drashish_chikhale@yahoo.com 
Dr. Ravaji Bhagwan Bhesania  Dhvani ENT Hospital,   Near G. P. O, Raopura, Vadodara-390001,-

 
0265-2428494, 09825044906

drbhesania@yahoo.co.in 
Dr. Athanikar Anant Martand  Dr. Athanikar E. N. T. Clinic  Opposite Garware College,Karve Road-411004
Pune
MAHARASHTRA 
020-25432941, 09822002242

dr.vinodnagure@yahoo.com  
Dr. S. Z. Jafrey  Dr. Jafrey's Indore Chest Centre  Morya Arcade, 1/2 Old Palasia, Indore-452018,-

 
0731-4064786, 2566788, 09424841786, 09425057864

drjafrey2001@yahoo.com 
Dr. Neelam Vaid   E. N. T. Department  K. E. M. Hospital Research Centre,Aasha Wing, 1st Floor, T. D. H. Building, 3rd Floor, Rasta Peth-411001
Pune
MAHARASHTRA 
020-25889483, 09822015073

neelu964@gmail.com  
Dr. Sanjiv Walanj  Ethika Clinical Research Center,   Prakruti Hospital, 1st Floor, ,Siddeshwar Arcade, -400605
Thane
MAHARASHTRA 
022-25386760, 09892721857

sanjiv_walanj@yahoo.com 
Dr. Mohan Vasant Jagade  J. J. Group of Hospital and Grant Medical College  WD 15, OPD-31, ENT Department, ,Byculla-400008
Mumbai
MAHARASHTRA 
022-3735555, 09323593627

mohanjagade@hotmail.com  
Dr. Balakrishnan R.  Kasturba Medical College & Hospital,  Department of ENT- Head & Neck Surgery, Kasturba Medical College & Hospital, ,Manipal- 576104-

 
0820-2922346, 09845383714

baluent@yahoo.com 
Dr. M. Sathiswaran  M. S. Clinic  38/16, 4th Lane, Appaswamy Pillai Thottam, Old Washeramanpet, Chennai-600021,-

 
09176216608, 09841368617

drmsathiswaran@yahoo.co.in 
Dr. Rakesh B. Shah  Manan Clinic,   Amar Complex, New Sama Road, Vadodara-8,-

 
0265-2785062, 09825051945

mananrs@rediffmail.com 
Dr. Sandeep Saboo  Saboo Hospital & Research Centre  14-7-24/27, Begum Bazar,-500012
Hyderabad
ANDHRA PRADESH 
040-24600896, 09849452520

dr_sandeepsaboo@rediffmail.com  
Dr. Anil R. Jawahirani   Satpratap Hospital  12 No. Puliya, Kamptee Road, Nagpur- 4,-

 
09822220936

anilramesh123@rediffmail.com 
Dr Aniket Chandrakant Joshi   Shree Swami Samrath Polyclinic  Sarthak Square, Near KEM Hospital, 3rd Floor, Rasta Peth, Pune-411011
Pune
MAHARASHTRA 
09890619523

drjoshianiket@gmail.com 
Dr. Pratik Desai  Shreeji Hospital  1st Floor, Vama Square, Ayurvedic Cross Road, Outside Panigate, Vadodara- 390019,-

 
0265-2561400, 09998968759

pratik_1973@indiatimes.com 
Dr. Sunil Singhvi   Singhvi Clinic  No. 127, Mini Street, Sowcarpet, Chennai -600079,-

 
044-25291012, 042160881

drsunilsinghvi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
CHL-Apollo Hospitals Ethics Committee, Convenient Hospital Ltd, A. B. Road, Indore-452008  Approved 
Ethics Committee of Biniwale Clinic, Bhandarkar Road, Pune  Approved 
Ethics Committee of Biniwale Clinic, Bhandarkar Road, Pune  Approved 
Independent Ethics Committee, Saboo Hospital and Research Centre, Begum Bazar, Hyderabad- 500012  Approved 
Institutional Ethics Committee, J. J. Group of Hospital and Grant Medical College, Mumbai  Approved 
K. E. M. Hospital Research Centre, 3rd Floor, T. D. H. Building, Rasta Peth, Pune-11  Approved 
Kasturba Medical College & Hospital, Institutional Ethics Committee, Manipal  Approved 
Maanav Health Foundation, Independent Ethics Committee, A-1, Anupam Nagar Society, B/H, Rajvee Tower, Near Tube Company, Old Padra Road, Vadodara- 390020  Approved 
Maanav Health Foundation, Independent Ethics Committee, A-1, Anupam Nagar Society, B/H, Rajvee Tower, Near Tube Company, Old Padra Road, Vadodara- 390020  Approved 
Maanav Health Foundation, Independent Ethics Committee, A-1, Anupam Nagar Society, B/H, Rajvee Tower, Near Tube Company, Old Padra Road, Vadodara- 390020  Approved 
Meet Independent Ethics Committee, Mumbai  Approved 
Midcity Independent Ethics Committee, Nagpur  Approved 
Midcity Independent Ethics Committee, Nagpur  Approved 
Midcity Independent Ethics Committee, Nagpur  Approved 
National Ethics Committee, Plot No. 148, Door No. 11, 101st Street, 15th Sector, KK Nagar, Chennai- 600078  Approved 
National Ethics Committee, Plot No. 148, Door No. 11, 101st Street, 15th Sector, KK Nagar, Chennai- 600078  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
  Seasonal Allergic Rhinitis  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Olopatadine IR   5 mg tablet twice daily for 10 days  
Intervention  Olopatadine OD   10 mg tablet once daily for 10 days  
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  Inclusion Criteria: 1. Subjects who have given written informed consent to participate in the study. 2. Subjects of either sex aged between 18 to 65 years (both inclusive) with a history of SAR for ≥ 1 year. 3. At the time of the enrollment subject should have an investigator assessed: (i) Total Nasal Symptom Score* of 4 -10 (both inclusive) and (ii) Nasal stuffiness score of ≤ 2. *Total Nasal Symptom Score (TNSS) will include assessment of rhinorrhoea, nasal stuffiness, nasal itching and sneezing using a 4-point scale for each (0 = no symptoms, 1= mild, 2 = moderate, 3 = severe).  
 
ExclusionCriteria 
Details  Exclusion Criteria: 1. Subjects with history of hypersensitivity to olopatadine or other antihistamines or any of the excipients of study formulations. 2. Subjects with history of upper respiratory tract infection (including otitis media) within 14 days prior to enrollment or history of sinusitis within 30 days prior to enrollment. 3. Subjects with nasal structural abnormalities (including deviated nasal septum, nasal polyps etc.). 4. Subjects with nasal, ocular or sinus surgery in past 6 months. 5. Subjects with history of disorders of nasolacrimal drainage. 6. Subjects with rhinitis medicamentosa (defined as a condition characterized by nasal congestion without rhinorrhea or sneezing that is triggered by the use of topical nasal decongestants for more than 4-6 days). 7. Subjects receiving immunotherapy except those on stable maintenance therapy for at least 6 months prior to enrollment in this study. 8. Subjects who have received intranasal/systemic corticosteroids in the past 4 weeks or cromolyn sodium in the last 2 weeks. 9. Subjects who have received astemizole in the past 4 weeks, loratadine/ desloratadine in the past 10 days, other oral/topical antihistamines or oral/topical nasal decongestants in the last 3 days. 10. Subjects who require concomitant use of drugs which can interfere with study evaluation including CNS depressants. 11. Subjects who would be requiring concomitant chronic or intermittent use of oral, intravenous, intramuscular, topical or inhaled corticosteroids. 12. Subjects with significant disease(s) or disorder(s) other than seasonal allergic rhinitis that in the opinion of the investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subject?s ability to participate in the study. 13. Subjects with history of substance abuse as per DSM IV criteria. 14. Pregnant or breast-feeding women or women of child-bearing potential not using medically acceptable methods of contraception or women with positive serum pregnancy test at screening. 15. Subjects with creatinine clearance of ≤ 35 mL/min (estimated from serum creatinine using the Cockcroft-Gault formula*). 16. Subjects with SGOT/AST, SGPT/ALT or alkaline phosphatase ≥2 times upper limit of normal (ULN), or total bilirubin ≥ 1.5 times ULN. 17. Subjects who are unable or unwilling to comply with the study procedures. 18. Subjects who have participated in another investigational study within the last 3 months prior to entry in this study. 19. Subjects who are likely to travel outside the study area for a substantial portion of the study period. 20. Subjects involved in hazardous tasks such as driving or operating machinery. *Creatinine clearance (Cockcroft ? Gault formula) = [140 ? age (years)] x weight (kg) ------------------------------------------------ (x 0.85 for female subjects) 72 x serum creatinine (mg/dL)  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Percent change in the total nasal symptom score (TNSS) over baseline  At the end of 10±2 days 
 
Secondary Outcome  
Outcome  TimePoints 
- Responder rate [defined as number of subjects having ≥ 50% reduction in total nasal symptom score (TNSS) over baseline]  At the end of 10±2 days 
- Assessment of medication effectiveness* by investigator and subject *Medication effectiveness rating will be done using 5 scale: (1 = complete relief, 2 = marked relief, 3 = moderate relief, 4 = slight relief, 5 = no relief/worse)   At the end of 10±2 days 
 
Target Sample Size
Modification(s)  
Total Sample Size="200"
Sample Size from India="200" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   No Date Specified 
Date of First Enrollment (Global)  20/01/2011 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Brief Summary   This study is a randomized, double-blind, comparative study with an objective to compare the efficacy, safety and tolerability of Olopatadine 10 mg extended release tablet once daily with Olopatadine 5 mg immediate release tablets twice daily for a period of 10 days for treatment of seasonal allergic rhinitis. The study is being conducted at 16 centres all over in India. The primary outcome is percent change in the total nasal symptom score (TNSS) over baseline and the secondary outcomes are responder rate [defined as number of subjects having ≥ 50% reduction in total nasal symptom score (TNSS) over baseline] and assessment of medication effectiveness* by investigator and subject using 5 point scale (1 = complete relief, 2 = marked relief, 3 = moderate relief, 4 = slight relief, 5 = no relief/worse). 
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