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NCT01280591 · ClinicalTrials.gov registry record · Phase 3
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 712
- Enrollment target
NCT01280591 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 712 participants.
The verdict
NCT01280591, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 712 participants
- Enrollment target
Study Summary
The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post-surgical dental pain and phase advanced sleep.
Interventions
- DRUG Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)
- DRUG Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)
- DRUG Naproxen sodium 440 mg (BAYH6689)
- DRUG DPH 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 712 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01280591
The ClinicalTrials.gov registry entry for NCT01280591 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 712 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 4 interventions - of which Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) is the first listed.
NCT01280591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01280591 about?
NCT01280591 is a clinical study titled "Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain". The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone i...
What is the current status of trial NCT01280591?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 712 participants. The study started on 2010-10. Estimated completion is 2011-02.
What interventions are being tested in trial NCT01280591?
The interventions under investigation include: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) (DRUG), Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) (DRUG), Naproxen sodium 440 mg (BAYH6689) (DRUG), DPH 50 mg (DRUG).
Who is sponsoring clinical trial NCT01280591?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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