Who is sponsoring NCT01330017?

NCT01330017 is sponsored by Bayer.

What condition does NCT01330017 study?

NCT01330017 studies Rhinitis, Seasonal Rhinitis.

What drugs are being tested in NCT01330017?

Interventions: Phenylephrine HCl, Placebo, Loratadine.

What is the status of NCT01330017?

NCT01330017 is currently COMPLETED.

Last reviewed 2015-02-20 · How we verify

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

NCT01330017 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Bayer
Phase	Phase 2
Status	COMPLETED
Enrolment	539
Start date	2011-03
Completion	2011-06

Conditions

Rhinitis
Seasonal Rhinitis

Interventions

Phenylephrine HCl
Placebo
Loratadine

Primary outcomes

Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score — Baseline, Day 7
The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.