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The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rhinitis, Allergic, Seasonal

Intervention: phenylephrine (Drug); pseudoephedrine (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover study, conducted at a single site in Austria, outside of the normal grass pollen season. An allergic reaction will be induced by exposing subjects to grass pollen in the Vienna Challenge Chamber (VCC). Subjects will receive a single dose of each of the following treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be a minimum of a 5-day washout period between each treatment. Subjects will complete symptom evaluations throughout the study. The nasal decongestant effects of phenylephrine will be compared to those of placebo using the subjective symptom evaluations. The safety profile (adverse events and vital signs) of the treatments will also be evaluated.

Clinical Details

Official title: Crossover Study of the Decongestant Effect of Phenylephrine Compared With Placebo and Pseudoephedrine as Active Control in SAR Subjects Exposed to Pollen in the Vienna Challenge Chamber

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo

Secondary outcome: The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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 evaluation time point during each of the

120-minute screening period challenge sessions: 1. Nasal Congestion Score of at least 2 (moderate); 2. Total Nasal Symptoms Score of at least 6; 3. Total Non-nasal Symptoms Score of at least 2.

- Freedom from any clinically significant disease, other than SAR, that would interfere

with the study evaluations. Exclusion Criteria :

- An upper or lower respiratory tract infection within 4 weeks before Screening.

- Dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines,

or nasal steroids, in the opinion of the investigator.

- A known potential for hypersensitivity, allergy, or idiosyncratic reaction to the

study drug or excipients.

Locations and Contacts

Additional Information

Starting date: January 2006
Last updated: October 31, 2014

Page last updated: August 23, 2015

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