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

NCT01413958 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 575

Last updated 2015-03-11

Study results available
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Summary

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

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Phenylephrine

Phenylephrine hydrochloride 30-mg extended-release tablets, one tablet every 12 hours for 7 days

DRUG

Placebo

Placebo to phenylephrine hydrochloride 30-mg extended release tablets, one tablet every 12 hours for 7 days

DRUG

Loratadine

Loratadine, 10 mg, once daily as rescue medication, only if needed for intolerable allergic rhinitis symptoms

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-10-31
Completion
2011-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01413958 on ClinicalTrials.gov