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NCT01048866 · ClinicalTrials.gov registry record · Phase 3
A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis
A Phase 3 study, sponsored by Reckitt Benckiser.
- Completed
- Registry status
- Phase 3
- Development phase
- 198
- Enrollment target
NCT01048866: Completed Phase 3 study, sponsored by Reckitt Benckiser.
NCT01048866 is a Phase 3 study that has completed, run by Reckitt Benckiser. The registered enrollment target is 198 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01048866, a Phase 3 study, has completed, sponsored by Reckitt Benckiser.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 198 participants
- Enrollment target
Study Summary
The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.
Primary Outcome
STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. The full range was -104412 (complete pain relief within 1 hour of dosing that lasts 24 hours) to 27588 (maximum pain within 1 hour lasting 24 hours) using the mean baseline STPIS. Participants with a last
Interventions
- DRUG placebo
- DRUG flurbiprofen
- DRUG acetaminophen 650mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
What the finished NCT01048866 record still lists
NCT01048866 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01048866 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01048866 about?
NCT01048866 is a clinical study titled "A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis". The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.
What is the current status of trial NCT01048866?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 198 participants. The study started on 2009-11. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01048866?
The interventions under investigation include: placebo (DRUG), flurbiprofen (DRUG), acetaminophen 650mg (DRUG).
Who is sponsoring clinical trial NCT01048866?
This trial is sponsored by Reckitt Benckiser, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01048866's enrollment target sits among peer trials
198 1389th of 2000 higher than 611 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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