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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00276016 | The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579) | PHASE3 | COMPLETED | 39 | — | — | Jan 1, 2006 | Feb 1, 2006 | Feb 9, 2022 | - | — |
To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing. The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results.
| Arm | Type | Description |
|---|---|---|
| Phenylephrine, Pseudoephedrine, Placebo | EXPERIMENTAL | Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. |
| Pseudoephedrine, Placebo, Phenylephrine | EXPERIMENTAL | Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. |
| Placebo, Phenylephrine, Pseudoephedrine | EXPERIMENTAL | Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. |
| Phenylephrine, Placebo, Pseudoephedrine | EXPERIMENTAL | Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. |
| Pseudoephedrine, Phenylephrine, Placebo | EXPERIMENTAL | Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. |
| Placebo, Pseudoephedrine, Phenylephrine | EXPERIMENTAL | Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. |
| Name | Type | Description |
|---|---|---|
| phenylephrine | DRUG | immediate-release 12 mg capsules for oral administration |
| pseudoephedrine | DRUG | 60 mg immediate-release tablets for oral administration |
| placebo | DRUG | placebo capsules |
Inclusion Criteria: * Skin test positive for the grass pollen allergen used in the chamber at Screening or within the prior 12 months. * A negative urine pregnancy test at Screening and at monthly intervals for female subjects of childbearing potential. * The following minimum scores at an evaluati...