Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
Public ClinicalTrials.gov record NCT01280591. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain With Phase Advanced Sleep
Study identification
- NCT ID
- NCT01280591
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bayer
- Industry
- Enrollment
- 712 participants
Conditions and interventions
Conditions
Interventions
- DPH 50 mg Drug
- Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) Drug
- Naproxen sodium 440 mg (BAYH6689) Drug
- Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2010
- Primary completion
- Dec 31, 2010
- Completion
- Jan 31, 2011
- Last update posted
- Jun 7, 2015
2010 – 2011
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Austin | Texas | 78744 | — |
| Not listed | Salt Lake City | Utah | 84124 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01280591, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 7, 2015 · Synced May 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01280591 live on ClinicalTrials.gov.