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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 is a Phase 4 study that has completed, run by Bayer. The registered enrollment target is 387 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03404206
The ClinicalTrials.gov registry entry for NCT03404206 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 387 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03404206 reports 0 study locations.
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.
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