CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 539 enrolled
Drug / intervention
Phenylephrine HCl +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.

Search/NCT01330017
NCT01330017Phase 2Completed
CompareCT.gov

A Randomized, Dose-ranging, Placebo-controlled Trial to Evaluate the Effects of Phenylephrine HCl Immediate Release Tablets on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis

Bayer·interventional·Posted Apr 6, 2011·Updated Mar 11, 2015

In Brief

A Phase 2 clinical trial evaluating Phenylephrine HCl, Placebo, and 1 other intervention for Rhinitis and Seasonal Rhinitis. Completed, enrolled 539 participants.

Detailed Summary

The trial will evaluate the nasal congestion symptom relief of the approved 10 mg phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo in participants with histories of seasonal allergic rhinitis, using loratadine as background medication.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinitis, Seasonal Rhinitis
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2011
Enrollment StartMar 1, 2011
Primary CompletionMay 1, 2011
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.2 years ago

Interventions

Phenylephrine HCldrug

10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days

Placebodrug

Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days

Loratadinedrug

10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.