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Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed)

NCT01330017 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 539

Last updated 2015-03-11

Study results available
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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.

Conditions

  • Rhinitis
  • Seasonal Rhinitis

Interventions

DRUG

Phenylephrine HCl

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

DRUG

Placebo

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

DRUG

Loratadine

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-05-31
Completion
2011-06-30

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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 NCT01330017 on ClinicalTrials.gov