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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 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 267 participants.

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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.

Interventions

  • DRUG DPH 50 mg
  • DRUG Naproxen Sodium 440 mg (BAYH6689)
  • DRUG Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)

Trial Details

FieldValue
Enrollment Target 267 participants
Start Date 2011-12
Est. Completion 2012-02
Phase Phase 3

Sponsor

Bayer

591 total trials

What the Registry Record Tells You About NCT01495858

The ClinicalTrials.gov registry entry for NCT01495858 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 267 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 3 interventions - of which DPH 50 mg is the first listed.

NCT01495858 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.