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NCT01986361 · ClinicalTrials.gov registry record · Phase 3
Placebo-Controlled Onset-of-Action Study of Flurbiprofen Utilizing the Double-Stopwatch Method
A Phase 3 study of Sore-throat and Acute Pharyngitis, sponsored by Reckitt Benckiser.
- Completed
- Registry status
- Phase 3
- Development phase
- 122
- Enrollment target
- 1
- Study location
NCT01986361: Completed Phase 3 study of Sore-throat and Acute Pharyngitis, sponsored by Reckitt Benckiser.
NCT01986361 is a Phase 3 study of Sore-throat and Acute Pharyngitis that has completed, run by Reckitt Benckiser. The registered enrollment target is 122 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01986361, a Phase 3 study of Sore-throat and Acute Pharyngitis, has completed, sponsored by Reckitt Benckiser.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 122 participants
- Enrollment target
- 1
- Study location
Study Summary
The study's purpose is to demonstrate the onset of action, i.e., time to meaningful pain relief in patients with pharyngitis, of flurbiprofen 8.75 mg lozenge using the Double-Stopwatch Method (DSW).
Primary Outcome
Time to meaningful pain relief is a patient-reported outcome (PRO) captured as part of the double stopwatch method. Participants depress the second stop watch when they experience what they perceive as meaningful pain relief. Instructions to participants are: "Stop the second stopwatch when the sore throat pain relief is meaningful to you. This does not mean you feel completely better, although you might, but when you feel relief of throat pain that is meaningful to you." Participants who did no
Conditions Studied
Interventions
- DRUG placebo
- DRUG flurbiprofen
Study Locations (1)
Connecticut
- University of Connecticut - Student Health Services - Storrs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT01986361 record still lists
NCT01986361 is an interventional study that assigns participants to a tested intervention. The registered 122 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 (84% lower).
The record links to 2 conditions, with Sore-throat appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01986361 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT01986361 about?
NCT01986361 is a clinical study titled "Placebo-Controlled Onset-of-Action Study of Flurbiprofen Utilizing the Double-Stopwatch Method". The study's purpose is to demonstrate the onset of action, i.e., time to meaningful pain relief in patients with pharyngitis, of flurbiprofen 8.75 mg lozenge using the Double-Stopwatch Method (DSW).
What is the current status of trial NCT01986361?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2013-09. Estimated completion is 2014-04.
What conditions does trial NCT01986361 study?
This clinical trial studies the following conditions: Sore-throat, Acute Pharyngitis.
What interventions are being tested in trial NCT01986361?
The interventions under investigation include: placebo (DRUG), flurbiprofen (DRUG).
Who is sponsoring clinical trial NCT01986361?
This trial is sponsored by Reckitt Benckiser, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01986361 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01986361's enrollment target sits among peer trials
122 1617th of 2000 higher than 382 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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