Phase 2
N=551
A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen
Rhinitis · Allergic · Seasonal
Bottom Line
View on ClinicalTrials.gov: NCT00291642 ↗Enrolled (actual)
551
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I — -3.80; -7.15; -7.05; -7.93 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo drops (Drug); Placebo tablets matching to levocetirizine (Drug); Placebo tablets matching to cetirizine (Drug); Levocetirizine drops (Drug); Levocetirizine tablets (Drug); Cetirizine drops (Drug); Cetirizine tablets (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Apr 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I |
-3.80; -7.15; -7.05; -7.93; -7.54 | <0.001 sig |
| SECONDARY Change From Baseline in the MSC Score Over Period II |
-3.50; -6.35; -7.07; -6.78; -7.92 | — |
| SECONDARY Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II) |
-3.61; -6.80; -7.10; -7.43; -7.72 | — |
| SECONDARY Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I |
-6.55; -11.33; -11.27; -12.71; -11.74 | — |
| SECONDARY Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II |
-5.73; -10.25; -11.03; -10.73; -12.14 | — |
| SECONDARY Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II) |
-6.10; -10.86; -11.22; -11.84; -11.92 | — |
| SECONDARY Change From Baseline in the Individual Symptom Scores Over Period I |
-0.60; -1.01; -0.95; -1.17; -1.04; -0.66 | — |
| SECONDARY Change From Baseline in the Individual Symptom Scores Over Period II |
-0.62; -0.86; -0.94; -0.95; -1.10; -0.57 | — |
| SECONDARY Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) |
-0.59; -0.94; -0.95; -1.07; -1.06; -0.61 | — |
Summary
The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.
Eligibility Criteria
Inclusion Criteria
- Female subject of non-childbearing potential or of childbearing potential agreeing not to become pregnant during the study.
- Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
- Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as defined by protocol
Exclusion Criteria
- Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
- Have used forbidden concomitant medications as defined by the protocol
Data sourced from ClinicalTrials.gov (NCT00291642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.