A Randomized, Double Blind, Placebo Controlled Study for Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup (CTZ DS) (2.5 mg or 5 mg Twice a Day) in Children (2 Years of Age or Older But Under 15 Years Old) Suffering From Perennial Allergic Rhinitis.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 239
- Locations
- 29
- Primary Endpoint
- Change in the total nasal symptom score (TNSS) during the total treatment period from the baseline
Study Overview
Brief Summary
Study objective is to verify the superiority of CTZ DS to the placebo groups in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 2 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in the total nasal symptom score (TNSS) during the total treatment period from the baseline
Time Frame: From Baseline to Day 14
TNSS is a sum of the nasal symptom score for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The Baseline value is defined as the average TNSS over the last 3 consecutive days prior to Day 1. For total treatment period, the average TNSS for each participant was calculated using available diary data from the total treatment period, taking the average of non-missing data during the period. Change from Baseline was calculated as the score at Baseline minus the mean score for the total treatment period.
Secondary Outcomes
- Changes in TNSS on the first and the second weeks of the treatment period from the baseline(From Baseline to Day 7 and Day 14)
- Investigator global improvement rating on the first day of Treatment Week 2 (Day 8) and the final observation day (Day 15 ) or at discontinuation (DC)(Day 8 and Day 15 or DC)
- Time-course changes in a total of daily mean nasal symptom scores (TDNSS)(From Baseline to Day 14)
- Mean scores for each nasal symptom and the time-course changes for the scores(From Baseline to Day 14)
- Participant global improvement rating on the first day of Treatment Week 2 (Day 8) and the final observation day (Day 15) or at DC(Day 8 and Day 15 or DC)
- Changes in each rhinoscopy finding (swelling and color of inferior conchal mucosa and aqueous secretion volume (ASV)) on first day of Treatment Week 1 (Day 1), the first day of Treatment Week 2 (Day 8) and the final observation day (Day 15) or at DC(Day 1, Day 8 and Day 15 or DC)