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NCT03404206 · ClinicalTrials.gov registry record · Phase 4
A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
A Phase 4 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 4
- Development phase
- 387
- Enrollment target
NCT03404206: Completed Phase 4 study, sponsored by Bayer.
NCT03404206 is a Phase 4 study that has completed, run by Bayer. The registered enrollment target is 387 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03404206, a Phase 4 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 387 participants
- Enrollment target
Study Summary
To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain. To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo. To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
Primary Outcome
Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment.
Interventions
- DRUG Placebo
- DRUG Naproxen Sodium (Aleve, BAY117031)
- DRUG Ibuprofen (Advil)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 387 participants |
| Start Date | 2018-02-12 |
| Est. Completion | 2018-07-10 |
| Phase | Phase 4 |
What the finished NCT03404206 record still lists
NCT03404206 is an interventional study that assigns participants to a tested intervention. The registered 387 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 (25% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03404206 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03404206 about?
NCT03404206 is a clinical study titled "A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain". To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction sur...
What is the current status of trial NCT03404206?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 387 participants. The study started on 2018-02-12. Estimated completion is 2018-07-10.
What interventions are being tested in trial NCT03404206?
The interventions under investigation include: Placebo (DRUG), Naproxen Sodium (Aleve, BAY117031) (DRUG), Ibuprofen (Advil) (DRUG).
Who is sponsoring clinical trial NCT03404206?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03404206's enrollment target sits among peer trials
387 222nd of 2000 higher than 1,779 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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