At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 575 enrolled
Drug / intervention
Phenylephrine +2 moredrug
Likely dose
Loratadine 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo-Controlled Trial to Evaluate the Effects of Phenylephrine HCl 30 mg Extended-Release Tablets on Nasal Congestion in Subjects With Allergic Rhinitis
In Brief
A Phase 3 clinical trial evaluating Phenylephrine, Placebo, and 1 other intervention for Seasonal Allergic Rhinitis. Completed, enrolled 575 participants.
Detailed Summary
This study will compare the nasal congestion symptom relief of phenylephrine extended release tablets and placebo in participants with allergic rhinitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2011
First PostedAug 2011
Primary CompletionOct 2011
TodayJul 2026
First PostedAug 10, 2011
Enrollment StartAug 1, 2011
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 14.9 years ago
Interventions
Phenylephrinedrug
Phenylephrine hydrochloride 30-mg extended-release tablets, one tablet every 12 hours for 7 days
Placebodrug
Placebo to phenylephrine hydrochloride 30-mg extended release tablets, one tablet every 12 hours for 7 days
Loratadinedrug
Loratadine, 10 mg, once daily as rescue medication, only if needed for intolerable allergic rhinitis symptoms