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Completed Phase 4 Interventional Results available

Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine

ClinicalTrials.gov ID: NCT01118273

Public ClinicalTrials.gov record NCT01118273. 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.

ClinicalTrials.gov public records Last synced May 19, 2026, 10:07 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-Blind, Randomized, Pilot Study Assessing the Analgesic and Hypnotic Effect of Naproxen Sodium and Diphenhydramine Combination in Dental Pain

Study identification

NCT ID
NCT01118273
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Bayer
Industry
Enrollment
162 participants

Conditions and interventions

Conditions

Interventions

  • DPH 50mg Drug
  • Ibuprofen 400 mg / Diphenhydramine citrate 76 mg Drug
  • Naproxen Sodium 220 mg (BAYH6689) Drug
  • Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg Drug
  • Naproxen Sodium 440 mg (BAYH6689) Drug
  • Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg Drug

Drug

Eligibility (public fields only)

Age range
16 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
Dec 31, 2007
Primary completion
Jan 31, 2008
Completion
Jan 31, 2008
Last update posted
Jun 7, 2015

2008

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
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 NCT01118273, 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 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01118273 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →