MedTrace Logo

Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)

NCT00976209 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2015-03-11

Study results available
· View outcomes & findings →

Summary

This is a randomized, two-way crossover, multicenter study evaluating the consumer preference of Phenylephrine Extended Release Tablets, 30 mg to be taken as one tablet every 12 hours, or Phenylephrine Immediate Release Tablets, 10 mg to be taken as one tablet every 4 hours in subjects with at least mild allergic rhinitis and nasal congestion. Approximately 250 participants will complete a questionnaire after taking one test product for 3 days followed by a 3 day (± 1 day) washout period; and then taking the alternate test product for 3 days. Analysis of which product the consumer preferred, if any, and which product was more convenient, if any, will be evaluated.

Conditions

  • Vasomotor Rhinitis
  • Seasonal Allergic Rhinitis

Interventions

DRUG

Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg

Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days.

DRUG

Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg

Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-11-30
Completion
2009-11-30

More Related Trials

Entities

Companies

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 NCT00976209 on ClinicalTrials.gov