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.
Trial Acronym
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
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
Patients
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)
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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).