A clinical study to see the effect of drug (Montelukast and Levocetirizine) in patients having irritation of the nasal passages associated with nasal dripping and itching of the nose and eyes (Allergic Rhinitis)

A Phase III, Multicenter, Double-Blind, Randomized, Three-Arm, Parallel-Group, Comparative Study To Evaluate Efficacy, Safety and Tolerability Of A Fixed Dose Combination of Montelukast 10mg and Levocetirizine 5mg Tablet Compared To Montelukast 10mg Tablet And Levocetirizine 5mg Tablet In Patients With Seasonal Allergic Rhinitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/10/002092

Enrollment

279

Registered

2011-10-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Allergic Rhinitis

Interventions

Intervention1: Fixed Dose Combination of Montelukast and Levocetirizine: 10mg/5mg Tablet, Oral, Once a day for two weeks. Control Intervention1: Montelukast: 10mg Tablet, Oral, Once a day for two week

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patientsâ?? 18 to 60 years. 2. Patient with history of seasonal allergic rhinitis with exacerbations during the study season associated and/or exhibiting a positive skin prick test to one of the regional allergens active during the study season. 3. Patients willing to give their written informed consent. 4. Patients willing to comply with the protocol requirements

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women. 2. Patient with known hypersensitivity to any of the components of the formulation. 3. Patient with a history of anaphylaxis and/or other severe local reaction to skin testing 4. Patient with alcohol or drug dependence. 5. Patient with a history of psychiatric illness. 6. Patient with an upper respiratory tract infection 7. Patient with current evidence of clinically significant hematopoietic, cardiovascular, hepatic renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subjectâ??s participation in the study. 8. Patient who have participated in any clinical trial in the past 1 month.

Design outcomes

Primary

Measure	Time frame
Daytime nasal symptoms scoreTimepoint: Two weeks	—

Secondary

Measure	Time frame
Daytime Eye Symptoms ScoreTimepoint: Two weeks;Nighttime Symptoms ScoreTimepoint: Two weeks;Patients Global Evaluation of Allergic RhinitisTimepoint: Two weeks;Physicians Global Evaluation of Allergic RhinitisTimepoint: Two weeks;Safety evaluation during treatment periodTimepoint: Two weeks	—

Countries

India

Contacts

Public ContactDr Shailendra Sachan

Glenmark Pharmaceuticals Ltd

piyusha@glenmarkpharma.com912240189999

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026