A clinical trial to study the effects of Olopatadine Extended Release Tablets, in patients with seasonal allergic rhinitis.

Phase 3

Completed

• Registration Number: CTRI/2010/091/001058
• Lead Sponsor: Ranbaxy Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

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).

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent change in the total nasal symptom score (TNSS) over baselineTimepoint: At the end of 10±2 days

Secondary Outcome Measures

Name	Time	Method
- Assessment of medication effectiveness* by investigator and subject<br>*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)<br>Timepoint: At the end of 10&plusmn;2 days;- Responder rate [defined as number of subjects having &amp;#8805; 50% reduction in total nasal symptom score (TNSS) over baseline]Timepoint: At the end of 10&plusmn;2 days