Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01744106 | A Multicenter Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold | PHASE3 | COMPLETED | 565 | — | — | Nov 1, 2012 | Apr 1, 2016 | Apr 22, 2016 | 11 | United States |
Weighted sum of change from baseline in Nasal Congestion Severity (NCSi) (instantaneous) scores over the first eight hours of treatment on Day 1
| Arm | Type | Description |
|---|---|---|
| pseudoephedrine hydrochloride 30 mg tablets | EXPERIMENTAL | Test product |
| placebo tablets | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| pseudoephedrine hydrochloride 30 mg tablets | DRUG | - |
| Placebo tablets | DRUG | - |
Inclusion Criteria: 1. Male or female subjects, ages 6 through 11 years, are experiencing the common cold, but are otherwise healthy. 2. Subjects have an onset of cold symptoms within the past 2.5 days before screening and are experiencing self-reported nasal congestion of at least stuffy severity ...