Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
pseudoephedrine · 1 trial · 1 indication
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 ...
Pseudoephedrine is used for the temporary relief of nasal congestion associated with the common cold. It is being studied in children aged 6 years and older for this indication. The drug is a small molecule and is currently in Phase 3 clinical development.
Pseudoephedrine is being developed by Perrigo Company plc, which trades under the ticker PRGO. The company is conducting clinical trials for the drug in the United States for the treatment of nasal congestion associated with the common cold.
Pseudoephedrine is in Phase 3 clinical development. It is an investigational drug for the temporary relief of nasal congestion associated with the common cold in children. The drug has completed one Phase 3 trial and is not yet approved.
Pseudoephedrine has one completed Phase 3 clinical trial, identified as NCT01744106. This multicenter study evaluated the drug for the temporary relief of nasal congestion in children with the common cold. The trial enrolled 565 participants in the United States and was randomized, double-blind, and placebo-controlled.
Pseudoephedrine is not FDA approved for the indication of nasal congestion associated with the common cold in children. It is currently in Phase 3 clinical development, meaning it is still being studied and has not yet received regulatory approval.
Pseudoephedrine is a small molecule used to relieve nasal congestion. It works by reducing swelling in the nasal passages, which helps to open up the airways and ease breathing. This mechanism is being evaluated in clinical trials for children with the common cold.