Safety Trial of Naproxen Sodium/ Diphenhydramine
Public ClinicalTrials.gov record NCT01365052. 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, Placebo Controlled, Parallel Group Safety and Tolerability Trial of Naproxen Sodium/ Diphenhydramine Combination in an OTC Population
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.
Study identification
- NCT ID
- NCT01365052
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 326 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2011 (Type not available)
- Primary completion
- Jul 2011 (Actual)
- Completion
- Jul 2011 (Actual)
- Last update posted
- Jun 8, 2015
2011
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Chandler | Arizona | 85224 | — |
| Not listed | Mesa | Arizona | 85203 | — |
| Not listed | Peoria | Arizona | 85381 | — |
| Not listed | Anaheim | California | 92801 | — |
| Not listed | Rancho Cucamonga | California | 91730 | — |
| Not listed | Sacramento | California | 95816 | — |
| Not listed | Colorado Springs | Colorado | 80922 | — |
| Not listed | Kissimmee | Florida | 34741 | — |
| Not listed | Pembroke Pines | Florida | 33028 | — |
| Not listed | South Miami | Florida | 33143 | — |
| Not listed | Stockbridge | Georgia | 30281 | — |
| Not listed | Metairie | Louisiana | 70006 | — |
| Not listed | Elkridge | Maryland | 21075 | — |
| Not listed | Warwick | Rhode Island | 02886 | — |
| Not listed | Mt. Pleasant | South Carolina | 29464 | — |
| Not listed | Fort Worth | Texas | 76135 | — |
| Not listed | San Angelo | Texas | 76904 | — |
| Not listed | San Antonio | Texas | 78231 | — |
| Not listed | Salt Lake City | Utah | 84106 | — |
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 NCT01365052, 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 8, 2015 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01365052 live on ClinicalTrials.gov.