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NCT01495858 · 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
- 267
- Enrollment target
NCT01495858: Completed Phase 3 study, sponsored by Bayer.
NCT01495858 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 267 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01495858, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 267 participants
- Enrollment target
Study Summary
The objective of the study is to evaluate the efficacy and safety of a single oral dose of naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with postsurgical dental pain and phase advanced sleep.
Primary Outcome
WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Interventions
- DRUG DPH 50 mg
- DRUG Naproxen Sodium 440 mg (BAYH6689)
- DRUG Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-02 |
| Phase | Phase 3 |
What the finished NCT01495858 record still lists
NCT01495858 is an interventional study that assigns participants to a tested intervention. The registered 267 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 (65% lower).
The record links to 0 conditions, and to 3 interventions - of which DPH 50 mg is the first listed.
NCT01495858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01495858 about?
NCT01495858 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 naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with postsurgical dental pain and phase advanced sleep.
What is the current status of trial NCT01495858?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 267 participants. The study started on 2011-12. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01495858?
The interventions under investigation include: DPH 50 mg (DRUG), Naproxen Sodium 440 mg (BAYH6689) (DRUG), Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) (DRUG).
Who is sponsoring clinical trial NCT01495858?
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 NCT01495858's enrollment target sits among peer trials
267 1222nd of 2000 higher than 779 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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