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NCT00377403 · ClinicalTrials.gov registry record · Phase 4
Treatment of Acute Sinusitis
A Phase 4 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 172
- Enrollment target
NCT00377403: Completed Phase 4 study, sponsored by Washington University School of Medicine.
NCT00377403 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 172 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00377403, a Phase 4 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 172 participants
- Enrollment target
Study 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.
Primary Outcome
The Sino-Nasal Outcomes Test (SNOT-16) assesses disease-specific quality of life for acute and chronic rhinosinusitis. This brief instrument assesses 16 sinus-related symptoms and was administered by phone. The respondent reported how much they were bothered by each item considering both its severity and frequency. Response options include no problem (0), mild or slight problem (1), moderate problem (2), severe problem (3). The SNOT-16 score is the mean score from all 16 items and ranges from 0
Interventions
- DRUG Acetaminophen
- DRUG Amoxicillin
- DRUG Guaifenesin
- DRUG Dextromethorphan hydrobromide with guaifenesin
- DRUG Pseudoephedrine Sustained Action
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2006-10 |
| Est. Completion | 2010-08 |
| Phase | Phase 4 |
What the finished NCT00377403 record still lists
NCT00377403 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT00377403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00377403 about?
NCT00377403 is a clinical study titled "Treatment of Acute Sinusitis". 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. Tw...
What is the current status of trial NCT00377403?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 172 participants. The study started on 2006-10. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00377403?
The interventions under investigation include: Acetaminophen (DRUG), Amoxicillin (DRUG), Guaifenesin (DRUG), Dextromethorphan hydrobromide with guaifenesin (DRUG), Pseudoephedrine Sustained Action (DRUG).
Who is sponsoring clinical trial NCT00377403?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00377403's enrollment target sits among peer trials
172 481st of 2000 higher than 1,517 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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