Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)

Summary

This study will compare the nasal congestion symptom relief of phenylephrine extended release tablets and placebo in participants with allergic rhinitis.

Timeline

Start

2011-08

Primary completion

2011-10

Completion

2011-10

Outcome

Missed primary endpoint

paper No significant beneficial difference was detected between PEH-MR and placebo for the primary end point PMID 26560899 ↗

paper P = .2655 PMID 26560899 ↗

Publications

• Meltzer EO, Ratner PH, McGraw T. Phenylephrine hydrochloride modified-release tablets for nasal congestion: a randomized, placebo-controlled trial in allergic rhinitis patients. Ann Allergy Asthma Immunol. 2016 Jan;116(1):66-71. doi: 10.1016/j.anai.2015.10.022. Epub 2015 Nov 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Phenylephrine	Small molecule	30 mg	Oral
Background	Loratadine	Small molecule	10 mg	—

Indications