CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 172 enrolled
Drug / intervention
Acetaminophen +5 moredrug
Likely dose
Acetaminophen 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00377403
NCT00377403Phase 4Completed

Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study)

Washington University School of Medicine·interventional·Posted Sep 18, 2006·Updated Dec 28, 2012

In Brief

A Phase 4 clinical trial evaluating Acetaminophen, Amoxicillin, and 4 other interventions for Acute Respiratory Infections and Acute Rhinosinusitis. Completed, enrolled 172 participants across 1 site.

Detailed Summary

This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 18, 2006
Enrollment StartOct 1, 2006
Primary CompletionMay 1, 2009
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 19.8 years ago

Interventions

Acetaminophendrug

Symptomatic treatment: Dose: 500mg every 4 to 6 hours for pain or fever

Amoxicillindrug

Intervention drug: Dose: 500mg tid for 10 days

Dextromethorphan hydrobromide with guaifenesindrug

Symptomatic treatment: Dose: 10mls every 4 to 6 hours for cough

Guaifenesindrug

Symptomatic treatment: Dose: 600mg every 12 hours to thin secretions

Pseudoephedrine Sustained Actiondrug

Symptomatic treatment: Dose: 120mg every 12 hours for nasal congestion

Saline spray (0.65%)drug

Symptomatic treatment: Dose: 2 squeezes per nostril as needed for nasal congestion